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CRO Update: Where are Contract Research Organizations Headed?

How CROs have adapted to recent challenges—and how they’ll continue to evolve in the future.

Contract research organizations (CROs) have undergone significant changes in recent years, and even more changes are on the horizon. Some of the new and established trends in CROs are the result of technological advances, while others have arisen in response to market pressures or the COVID-19 pandemic. Experts say that spending on research and development has continued to grow over the last 15 years, even as the pandemic has caused biotech stocks to slump. However, CROs continue to face a variety of challenges, from competitive pressure to commoditization to evolving patient engagement models. Market stratification is placing pressure on smaller CROs to niche down or subcontract as larger organizations capture more of the market. As CROs navigate a post-pandemic future, there will be opportunities to implement lessons learned from COVID-19 and adopt emerging technologies that can improve data management, mitigate staffing shortages, or facilitate better patient monitoring and engagement.

In Focus: Amid Heightened Industry Rules on Sustainability, How are CROs Faring?

With investors embracing the new regulations, a look at the progress CROs are making in their sustainability efforts

Tips to Rescue a Clinical Trial Before It’s Too Late

Why constant communication and transparency are paramount to successful partnerships between pharmaceutical companies and CROs

Focus on Fundamentals for Better Collaboration Across Research Sites and Sponsors

Improving the site-sponsor relationship can get trials off on the right foot and on a path for success.

When FMVs Collide: Coming to Terms with Fair Market Value

With variation in costs between different stakeholders in clinical trials, there is often disagreement on fair market value.

Top 3 Most Read CRO/Sponsor Feature Articles of 2023

Authors highlighted outsourcing and the impact of the COVID-19 pandemic in these CRO/sponsor articles from 2023.

Anticipating Near-Term Structural Change in the Outsourcing Landscape

Can full-service outsourcing to CROs by large biopharma companies sustainably prosecute a clinical development portfolio?

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Top 10 largest clinical research organizations

We take a look at the 10 biggest contract research organizations in the pharma sector in 2022.

The drug discovery process is complex. The clinical stage is particularly resource-intensive, something that has led to the rise in demand for contract research organizations (CROs) that can support drug manufacturers at each stage of the process, from discovery to approval. The core activities a CRO can provide include (but are not limited to) clinical trial management, data research and project management.

Despite an initial downturn at the start of the pandemic, Covid-19 created a spike in the number of clinical trials taking place due to the need for vaccines and drugs to tackle the virus.  In the coming years, we expect the rise of technologies that enable decentralized clinical trials to help expand the market share of CROs.

Currently the global CRO services market is projected to grow from US$73.38 bn to $163.48 bn by 2029. Here Pharma IQ takes a look at the 10 biggest CROs in pharma today.

Founded in 1982, IQVIA is an American multinational company formed through the merger of Quintiles, a leading provider of product development and integrated healthcare services, and IMS Health, a global information and technology services company. The latter has enabled company to have a strong focus on digital solutions and analytics. In 2017, Quintiles IMS rebranded to IQVIA.  

Laboratory Corporation of America Holdings, also known as Labcorp, is an American company that operates one of the largest clinical laboratory networks in the world. In an average week Labcorp processes tests on more than 3 million patient specimens. In 2020 the company earned revenue in excess of $14 bn.

Syneos Health

Founded in 1999, Syneos Health was created following the merger of two biopharmaceutical companies: INC Research and inVentive health. Today it has offices in more than 110 countries and offers services as a CRO as well as consultancy.  

Founded in 1985 as a one-person consultancy firm, Pharmaceutical Product Development (PPD) is a global contract research organization that provides drug development, lab and lifecycle management services. In 2020 the company made US$4.7bn and the following year it became part of Thermo Fisher Scientific.

Headquartered in Dublin, Icon provides strategic management and support for clinical development from the compound selection stage through to clinical trials. Its services include  clinical trials management, biometric activities, investigator recruitment and outcomes research.

Parexel was founded in 1982 and acquired by private equity firm Pamplona Capital in 2017 in a deal worth $5 bn. In 2021 it was bought by EQT Private Equity and Goldman Sachs Asset Management.  The company conducts clinical trials and operates in more than 50 countries. It makes around $3 bn in revenue annually.

Charles River Laboratories

Founded in 1947, today this company specializes in cell and gene therapies as well as lab services for the pharmaceutical, medical device and biotech industries. As of 2021 it operates more than 90 facilities in 20 countries and has an annual revenue of $3.54 bn.

Award-winning MedPace has offices on six continents, with headquarters in Ohio where it has a clinical research campus and a number of clinical and bioanalytical laboratories. It provides clinical trial services for Phase I-IV studies in the biotech, pharma and medical device industries. Its revenue has been growing steadily year- on-year and is currently almost $1 bn.

CTI Clinical Trial and Consulting Services

This organization was founded in 1999 to provide clinical trial services and bring new drugs to market. It operates in more than 60 countries and since its inception has contributed to the approval of more than 150 new drugs and medical devices around the world.

WuXi AppTec 

Founded in 2000 in Shanghai, WuXi AppTec is the newest company in our top 10. It provides services across the entire development cycle including small molecule R&D and manufacturing, biologics R&D and manufacturing, cell and gene therapy. It currently operates in 18 locations across China, Iceland and the US.

Quick links

• How to improve the success rate of clinical trials
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Clinical trials

Drug clinical trial news involving companies such as Intellia, ActiGraph, Light Sciences Oncology, Nektar Therapeutics, Vir and Bellerophon Therapeutics, and drugs such as lecanemab and Wegovy. There’s also coverage of how to increase diversity in pharmaceutical clinical trials, animal welfare in clinical research, and an in-depth story on why a failed clinical trial doesn’t always spell doom for a new drug.

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Clinical Trials

Lilly obesity drug shows heart benefit in late-stage trial

The drug led to a 38% reduction in the risk of death or complications from a type of heart failure, a finding that compared favorably to available treatments.

Pfizer’s Bourla confident in company’s obesity drug position, despite delays

The CEO noted how Pfizer's danuglipron could still be the second oral GLP-1 treatment to enter registrational tests after Lilly's orforglipron.

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

Ventyx’s TYK2 drug suffers second setback

The company claimed “higher than anticipated” scores from trial volunteers on placebo led to the disappointing data, prompting it to halt internal trials.

NewAmsterdam heart drug hits trial goal, but data appear to disappoint investors

The study is the latest test of a class of cholesterol medicines known as CETP inhibitors, which were abandoned by several large drugmakers last decade.

Viking shares jump on plans to speed obesity drug into late-stage testing

The drug’s advancement continued what one analyst described as a “torrid” pace for Viking’s closely watched medicine, which started human testing in 2022 and could reach a Phase 3 trial next year.  

Biogen, Sage tremor drug fails key trial

Known as SAGE-324, the drug was one of the key assets Biogen gained rights to through a billion-dollar research deal inked back in 2020.

Merck claims late-stage study success for RSV antibody

The drug, a rival to Sanofi and AstraZeneca’s fast-selling Beyfortus, met its main goals in a Phase 3 trial. But undisclosed study results leave its full potential unclear.

Ionis plots next steps for Angelman drug Biogen passed on

The company plans to start a late-stage study next year, after a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function.

Obesity pill from Roche shows promising weight loss in small study

Treatment led to "clinically meaningful" weight loss over four weeks, but longer studies will be needed to compare it to Wegovy and Zepbound.

Lexeo gene therapy shows signs of heart benefit in small study

The biotech, which went public late last year, argued the results justify exploring an accelerated approval. But shares fell by double digits amid investor skepticism.

UniQure stock surges on data for Huntington’s gene therapy

The biotech’s stock rose more than 60% as fresh data appeared to alleviate some investor concerns about the therapy’s effectiveness and reliability.

HilleVax’s norovirus vaccine ineffective in large trial of infants

Shares in HilleVax plummeted after the company reported its experimental shot failed to meet the primary and secondary goals of the Phase 2b study.

10 clinical trials to watch in the second half of 2024

Study results are expected for two closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.

Novo nixes trial of blood pressure drug it bought in $1.3B deal

The failure of a Phase 3 study led the Wegovy maker to take an accounting charge that will hit its operating profit growth this year.

Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?

Obesity drugs like Wegovy are proving useful in many diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.

First-of-its-kind Intellia data suggest CRISPR drug could be given more than once

The findings provide early proof that multiple doses of a gene editing medicine can be safely administered with additive effects, overcoming a key constraint of the complex therapies.  

Wave, with new data, plots path forward for Huntington’s drug

The company plans to make a case to regulators for a new accelerated approval pathway. But investors didn't seem as hopeful, sending shares down by double digits.

Novo fills in positive picture for preventive hemophilia drug

Phase 3 trial results should support an approval application for the drug, which analysts view as a competitor to Roche’s blockbuster medicine Hemlibra.

Alnylam says heart drug succeeds in closely watched study

Positive results from a Phase 3 trial of vutrisiran in transthyretin amyloidosis cardiomyopathy come eight months after the FDA rejected another medicine Alnylam developed for the condition.

Bridging science and humanity: Systems thinking in clinical trial design

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Obesity drug from Zealand shows potential in early trial

Interim study data suggest the Danish drugmaker can remain in the race to develop new kinds of weight loss drugs as doctors seek alternatives to the now dominant GLP-1s.

FDA lifts hold on PTC Huntington’s disease trial

The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.

Twice-yearly shots of Gilead HIV drug effective in large prevention study

Researchers recommended Gilead end testing early as lenacapavir proved 100% effective in protecting cisgender women in the Phase 3 trial.

Intra-Cellular depression drug succeeds in second late-stage study

The results position the company to unlock what’s believed to be a multibillion-dollar sales opportunity for Caplyta, which is already used to treat schizophrenia and bipolar disorder. 

Takeda drug for rare types of epilepsy misses goal in late-stage trial

Called soticlestat, the drug had seemed promising in earlier studies for people with Dravet and Lennox-Gastaut syndrome, enough to persuade Takeda to take on full rights to the drug.

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First WHO Global Clinical Trials Forum puts forward a global vision for sustainable clinical research infrastructure

About 130 experts from 43 countries with strong global south representation participated in person, and many more virtually participated in the first WHO Global Clinical Trials Forum on November 20-21, 2023.

The objectives of the forum were to:

• Develop a joint vision on strengthening clinical research capabilities aligned with the World Health Assembly resolution (WHA75.8)  ( Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination );
• Discuss how we can help build, enhance, and sustain functional clinical trial capacity that is used all the time and providing utility by addressing day-to-day issues of local clinical and public health importance;
• Provide an update on clinical research capabilities by region and globally, including key clinical research networks. 

During the summit, experiences and lessons learned were exchanged between various disciplines and disease/ health condition areas. Trialists and clinical scientists from various areas of expertise, including cancer, cardiovascular disease, metabolic and neurological disorders, were in attendance.

Additionally, experts from mental health, tuberculosis, HIV, malaria, maternal and child health, ageing, vector-borne diseases including dengue fever, antimicrobial resistance (AMR), emerging infectious diseases, neglected tropical diseases also participated. 

Apart from those, regulators, ethicists, research funders, patient groups and community engagement experts were part of the forum. Industry groups, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Developing Countries Vaccine Manufacturers Network (DCVMN), International Generic and Biosimilar Medicines Associations (IGBA), contract research organizations and several product development partnerships were represented. During the engagement, there were specific focuses on clinical trials in primary health care and intensive care units and in-hospital and vaccine trial settings.

The meeting’s opening session included presentations on the status of the national and regional trial ecosystem in each of the six WHO regions. Moreover, barriers and areas of focus to address these identified were also discussed with stakeholders in their respective countries.

During the two-day discussions, participants called for several priority actions for strengthening the clinical trials ecosystem, including:

• National support for clinical trial infrastructure, including sustained domestic funding as is possible in each country;
• Improving coordination and streamlining of regulatory and ethics review and approval processes;
• Enhancing engagements with patients, the public and communities throughout the clinical trial process;
• Addressing barriers to clinical trials in underrepresented populations such as children and pregnant women;
• Enabling clinical trials with digital and information technologies;
• Accelerating access to fit-for-purpose training packages for clinical trials, including innovative design; and
• Engaging clinical practitioners to integrate clinical trials into health systems and practices.

The anticipated outcomes from these actions would change the clinical trial landscape with fewer, well-designed trials generating compelling evidence for improved policy and practices that lead to improved outcomes in patients and population health. The actions would also lead to sustained capacity-building and a streamlined learning process for stakeholders involved in clinical trials.

More From Forbes

Contract research organizations: key partners in the drug development journey.

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Nick Lucas is Senior Vice President of Professional Services and Site Leader for EMEA at  Medidata Solutions .

Outsourcing of non-core services and resources is common practice in today’s world as companies look to reduce overhead and costs and streamline their businesses. Pharmaceutical companies outsource their clinical research capabilities to contract research organizations (CROs) for a number of reasons, including therapeutic expertise of the CRO, cost benefits and geographic reach. But, ultimately, they do it to help bring new drugs and treatments to patients faster.

CROs have been around for decades — they first emerged in the 1940s and 1950s with the likes of Huntingdon Life Sciences and Charles River Laboratories. While CROs are the outsourcing partner for the life sciences sector, other industries are equally familiar with the concept. Tech companies, for example, have also been key proponents of outsourcing over the years. Skype used outsourcing services to create the back-end development of its app and Google has ramped up its outsourcing strategy, working with companies such as Cognizant .

CROs in clinical research range from global players who cover every part of the clinical trial process, every therapeutic area and every geography to smaller niche players who might specialize in a specific disease area. With over a thousand CROs worldwide, the CRO market is expected to grow by 12% in 2022 and reach $71.7 billion by 2024. While healthcare companies are well versed on the benefits of outsourcing, there are a number of key principles to adopt in order to maximize the success of using a CRO.

CROs Are Experts In Their Field

The Covid-19 pandemic has put the pharmaceutical industry in the spotlight, sparking increased levels of public interest in the clinical development process. It is widely recognized that the latest advances in the industry and the clinical successes during the pandemic would not have been possible without the help of CROs.

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As experts, when it comes to niche areas and wider technologies, CROs are a valuable resource for pharmaceutical companies (or “sponsors”). They are quick to adopt the latest technologies, enabling them to provide unique insights and advice, spotting novel and distinctive ways of using these advanced tools and adapting them to each sponsor's needs to ensure optimal clinical trial performance. Some CROs even have their own unique technology offerings. The global CRO ICON, for example, develops technologies like PDx-Pop to integrate existing tools and its own methods to accelerate the process of population pharmacokinetic modeling and analysis.

In clinical trials, speed is fundamental, and this has been even more important in battling Covid-19, with pressure on the industry to deliver a vaccine in the shortest time possible. While sponsors play an important role in these clinical trials, the delivery wouldn’t have been possible without the expanded expertise and vast resources brought by partnering with CROs. Johnson & Johnson, for example, has been leveraging IQVIA’s virtual trial solutions for their Covid-19 vaccine trials. NonCovid-19 trials have been equally challenged by the restrictions caused by the pandemic, as patients have been unable to visit hospitals. In many cases, this was resolved through technology and the rapid uptake of virtual trials.

With the increase of personalized medicine and the one-size-fits-all model becoming obsolete, coupled with the industry drive to make trials more accessible and less burdensome for patients, technology has become a key element in clinical trials. CROs are at the forefront of implementing the latest technologies and tools available, both to maintain competitive advantage and ensure they’re able to offer customers the full spectrum of available solutions. Given that the global CROs work with hundreds of sponsors, they have a learning curve and breadth of experience beyond any single sponsor (even a big pharma).

Setting Up For Success

CROs should be considered more than just useful resources — they should be thought of as partners in the drug development process. To ensure the partnership runs smoothly, sponsors should keep a few things in mind:

• Selection: Selecting the right CRO is crucial, as each CRO’s expertise and reach varies. A thorough vetting process offers a chance to get an information download about the CRO and how they can help a sponsor meet their clinical objectives. CROs come in different shapes and sizes and different geographical spread or technical and therapeutic ability. Geographical reach or therapeutic focus can be very important in patient recruitment, especially if a trial requires a specific population group.

• Governance: Establishing an effective governance structure between parties is core to the success of the partnership. It must be underpinned by the allocation of roles and proper escalation procedures. Given the complexity of clinical trials, this ensures all parties can effectively manage the scope of a project and stay aligned on process, deliverables and expectations.

• Success metrics: A CRO and sponsor should determine how to monitor success to ensure they are both getting the most out of the partnership. Setting performance indicators is a good way of ensuring efficiency. While sponsors may be tempted to enforce specific standards or structures on CROs, adopting another organization’s standards is often less effective than a CRO working to their own standards. This means putting trust in the CRO — they are the experts and know what they are doing.

• Communication: As with any partnership, communication is key. Having regular and transparent communication between all parties involved is absolutely crucial. This alone can help avoid most issues.

CROs Are Here To Stay

CROs have played an important role in the pharmaceutical industry over the past few decades and have grown to be more than a simple outsourcing resource. They are experts in the space, active partners in clinical research, and they are contributing massively to the industry’s success. Sponsors should embrace these partnerships, and by establishing clear performance indicators and setting standards and a clear governance structure, they will be well on the way to a fruitful relationship.

In an industry where time is of the essence, CROs are a fantastic resource, and they play a key role in the success of many studies and in helping bring much-needed drugs and treatments to patients. Make the most of them.

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Top 15 Contract Research Organizations (CROs) in 2024

Post-pandemic, as drug development businesses recover and grow, CROs around the world continue to undergo profound transformation. As in previous years, 2023 will be all about mergers and acquisitions, with big players getting even bigger and smaller companies surviving thanks to niche advantages such as technological know-how or brilliant scientists among their employees.

The top 15 CROs globally would be in the following order based on 2023 revenue :

• LabCorp (Covance) , with 15.05 billion USD (2023) and 75000 employees ( Labcorp , 2024).  In February 2015, Labcorp completes its $6 billion purchase of Covance, Inc., creating the world’s leading health care diagnostics company. The combination of Covance’s drug development leadership and Labcorp’s medical testing expertise builds the market leader in central laboratory and bioanalysis services. Labcorp’s clinical trials companies, Labcorp Clinical Trials and Tandem Laboratories, align under the Covance brand.  
• IQVIA , with 14.85 billion USD  (2023) and 86000 employees (IQVIA, 2022). IQVIA, formerly Quintiles and IMS Health, Inc., is an American Fortune 500 and S&P 500 multinational company serving the combined industries of health information technology and clinical research.  IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries.  
• ICON (PRA) , with 7.74 billion USD (2022) and 41160 employees (ICON, 2023). From a small team of 5 people in 1990, ICON now employs over 41,100 people.  ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile  industry awards .  
• Thermo Fisher Scientific (PPD) , with 7.02 billion USD (2023) and 35000 employees (Businesswire, 2023). Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, we serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, we apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.  
• Lonza - 6.5 billion USD,   17896 employees. Though being a contract development and manufacturing organization (CDMO), rather than a CRO, takes the 10th position with the 5.9 billion USD in sales and over 17500 employees worldwide (2023), offering “proprietary line of in silico and in vitro services for manufacturability, immunogenicity, potency assessment, humanization and protein engineering” ( https://pharma.lonza.com , 2022). Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 17,500 full-time employees, it comprises high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The business benefits from global supply chains, but we have worked to maintain the agility to address marketplace needs on a local level. CDMOs become reliable partners for Pharma companies as their “services reduce R&D costs while improving productivity and are essential to providing safe and effective treatment to patients” ( https://pharma.lonza.com , 2022.  
• Wuxi AppTec with 5.8 billion USD revenue in 2021 and 44360 employees (Companiesmarketcap, 2022). As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."  

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.  

Cell and Gene Therapy CDMO Solutions has supported the development of 11 FDA approved cell and gene therapies and have conducted more than 900 studies in this field over the past year. Unsurpassed end-to-end offering results in enhanced access to scientific and regulatory expertise via multidisciplinary bench of experts to help you problem solve.   

Parexel (EQT Private Equity and Goldman Sachs Asset Management) with 3.8 billion USD in 2022 and 21000 employees (Parexel, 2023). Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.  

• Medpace Holdings, Inc. with 1.135 billion USD revenue in 2021 and 5400 employees (Medpace, 2023). Integrating core clinical trial services delivers efficient and streamlined execution and higher quality results. Through its wholly-owned subsidiaries, Medpace offers clinical pharmacology, as well as supporting laboratory services including central labs, bioanalytical lab, ECG core lab, and imaging core labs.  

Worldwide Clinical Trials – 0.6 billion USD , 3000 employees, 60 countries.

Worldwide Clinical Trials started out more than 30 years ago as a small science team with a big goal: To always provide authentic, personalized attention to our partners. And as the industry has grown, CROs have merged, and trials have grown increasingly complex, we haven’t forgotten what truly matters: People.

With more than 3,000 employees in more than 60 countries around the world, we’re still staying true to those roots. Our team is dedicated to staying accessible, flexible, and solution-focused to ensure our partners not only have the best possible outcomes – but they also know their Worldwide team is only a call away.  

Allucent (CATO SMS and Pharm-Olam) – 0.36 billion USD, 1200+ employees .

Allucent originated with CATO SMS, itself created by the merger of Cato Research and SMS-oncology in 2019. Cato Research, founded in 1988, was known for its ability to design and execute successful development strategies and guide creative new products through the regulatory process.

Previous acquisitions by CATO SMS included Array Biostatistics, a full-service biostatistical and statistical programming CRO, and Nuventra Pharma Sciences, one of the industry’s leading providers of clinical pharmacology science and services. With these acquisitions, CATO SMS expanded its services to offer biostatistical consulting, analysis, programming, and cutting-edge modeling and simulation techniques to inform clinical trial designs and predict trial outcomes.

In early 2022, CATO SMS merged with Pharm-Olam, a global clinical research organization delivering clinical trial services to organizations around the world.  

KCR – 0.15 billion USD, 700 employees  

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations.

Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting, and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston, US, Berlin, Germany, and Warsaw, Poland.

Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people.  

Advanced Clinical – 0.1 billion USD , 1100+ employees

Today, Advanced Clinical has grown organically, with coverage across North America, Eastern Europe, Western Europe and Asia-Pacific, providing contract research organization (CRO), FSP and strategic resourcing solutions. A research services and strategic resourcing organization committed to providing a better clinical experience by delivering comprehensive Contract Research Organization (CRO), Functional Service Provider (FSP) and Strategic Resourcing services that optimize effectiveness for both patients and sponsors throughout the clinical research journey.

Using our decades of experience, we strive to improve the lives of everyone touched by clinical research and help our clients achieve better outcomes through candid conversations, foresight, resilience and innovative solutions.  

CTI Clinical Trial and Consulting Services – 0.08 billion USD, 750 employees . CTI has grown consistently and significantly, becoming a global organization with associates in more than 60 countries across the world. We have worked on more than 10,000 projects, worked on every continent except Antarctica, and have contributed to more than 150 new drug and device approvals through global regulatory agencies such as the FDA, EMA, and others. Currently, we work with approximately 250 pharmaceutical and emerging biotechnology and medical device companies.

Among recent reasons for mergers and the whole new approach to conducting clinical research, apart from pursuit of new clients, talents, expertise, products, and markets, there have been notorious coronavirus crisis and military conflicts worldwide. We faced the advent of globalization, decentralization, remote monitoring, and personalized approach to drugs R&D. But we are now looking into the era of technology in clinical research. Processes that allow remote audits and monitoring, previously considered too risky, are now risk mitigators (Bahls, Christine, 2021), at least from that point of view. Clinical trial participants enrollment, and even participation itself, constantly moves into tech dimension.

Only few among the leading CROs escaped M&As for now, but this seems to be the matter of time. Savlovschi – Wicks, Theodora (2022) estimated that “in 2021, the global CRO market is expected to reach an impressive US$88 billion by 2028”. According to IQVIA , only in biopharma sector the total transaction value grew by 70% to reach 152 billion USD by the end of 2023, featuring prominent $43Bn Pfizer-Seagen deal, and other considerable M&As for BMS-Karuna ($14Bn), Merck-Prometheus ($10.2Bn), AbbVie-Immunogen ($10.1Bn), AbbVie-Cerevel ($8.7Bn), Biogen-Reata ($7.3Bn) and Roche-Telavant ($7.1Bn).

Among the CRO businesses the following M&As took place lately:

• Charles River Labs acquires  MPI Research (2018), Citoxlab (2019), HemaCare (2020) and Cognate BioServices (2021)
• IQVIA (formerly Quintiles and IMS Health) acquired Clintec and 40% of Q2 Solutions (2021)
• ICON purchased PRA Health Services (2021)
• Thermo Fisher Scientific bought PPD (2021)
• Labcorp purchased Covance and Chiltern
• Inotiv acquired Envigo (2021)
• INC Research and inVentiv Health merged to later become Syneos Health
• Parexel become the property of EQT Private Equity and Goldman Sachs Asset Management
• CATO SMS and Pharm-Olam merged in 2022
• Triley Bidco acquired Clinigen (2022)

The article by Nataliia Vietchinkina, MS in Clinical Research Administration

University of Liverpool. 

References:

• Christine Bahls (2021) ‘The Post-Pandemic CRO Landscape’, Applied Clinical Trials, Applied Clinical Trials-09-01-2021, Volume 30, Issue 9 [online] Available from: https://www.appliedclinicaltrialsonline.com/view/the-post-pandemic-cro-landscape
• Savlovschi – Wicks, Theodora (2022) ‘Top 10 CROs to watch in 2022’ [online]. Available from: https://www.proclinical.com/blogs/2022-3/top-10-cros-to-watch-in-2022
• Labcorp (2022) Labcorp Announces 2021 Fourth Quarter and Full-Year Results, 10 February 2022 [online]. Available from” https://ir.labcorp.com/news-releases/news-release-details/labcorp-announces-2021-fourth-quarter-and-full-year-results#:~:text=Revenue%20was%20%2416.12%20billion%20%2C%20an,by%20divestitures%20of%20(0.1%25)
• IQVIA (2022) IQVIA Reports Fourth-Quarter and Full-Year 2021 Results; Raises Full-Year 2022 Profit Guidance, 15 February 2022 [online]. Available from: https://ir.iqvia.com/press-releases/press-release-details/2022/IQVIA-Reports-Fourth-Quarter-and-Full-Year-2021-Results-Raises-Full-Year-2022-Profit-Guidance/default.aspx#:~:text=Revenue%20of%20%2413%2C874%20million%20for,12.4%20percent%20at%20constant%20currency
• ICON (2022) ICON Reports Fourth Quarter and Full Year 2021 Results, 2022 [online]. Available from: https://www.iconplc.com/news-events/press-releases/icon-reports-fourth-quarter-and-full-year-2021-results/
• Businesswire (2021) ‘PPD Reports Fourth Quarter and Full Year 2020 Results’, 23 February 2021 [online]. Available from: https://www.businesswire.com/news/home/20210223006094/en/PPD-Reports-Fourth-Quarter-and-Full-Year-2020-Results
• Macrotrends (2022) ‘Syneos Health Revenue 2012-2021 | SYNH’ [online]. Available from: https://www.macrotrends.net/stocks/charts/SYNH/syneos-health/revenue
• https://companiesmarketcap.com/ (2022) ‘Revenue for Charles River Laboratories (CRL)’ [online]. Available from: https://companiesmarketcap.com/charles-river-laboratories/revenue/
• Vinluan, Frank (2021) ‘CRO Parexel changes private equity hands again, this time for $8.5B’ [online]. Available from: https://medcitynews.com/2021/07/cro-parexel-changes-private-equity-hands-again-this-time-for-8-5b/
• Medpace (2021) ‘Medpace Holdings, Inc. Reports Third Quarter 2021 Results’ [online]. Available from: https://investor.medpace.com/news-releases/news-release-details/medpace-holdings-inc-reports-third-quarter-2021-results#:~:text=The%20Company%20forecasts%202021%20revenue,%24176.0%20million%20to%20%24180.0%20million%20 .
• Companiesmarketcap (2022) ‘Revenue for WuXi AppTec (2359.HK) Revenue in 2021 (TTM)’ [online]. Available from: https://companiesmarketcap.com/wuxi-apptec/revenue/
• https://pharma.lonza.com (2022) ‘Design, assess and optimize for clinical success’ [online]. Available from: https://pharma.lonza.com/offerings/early-development-services .

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Top 17 Clinical Research Organizations (CRO) in 2023

In clinical research and treatment development, clinical research organizations (CROs) are frequently a sponsor’s most important partner and ally.

Depending on the nature of the clinical trial, and your existing capabilities as a sponsor to run the trial, the CRO company of your choice will typically be responsible for facilitating most of the micro and macro processes that go into designing and running a successful clinical trial.

When contracting a CRO to help you with your trial, you are transferring over a large portion of responsibility into the hands of your clinical research partner. The CRO of your choice will have the responsibility to control a variety of factors and processes of a clinical trial, and depending on their expertise, team structures, service offerings, internal resources and many other capabilities.

Your ability to find and contract a top CRO company that is the right fit for your unique trial will be a determinant of whether or not you will be able to operate a high-quality clinical trial that meets your expected timelines, budget and delivers a top-notch patient experience.

At ClaraHealth (a patient-centric recruitment acceleration platform) , we have put together an extensive list of the top CRO companies in the US and around the world.

This is not a cro rankings list, but rather a compiled list of some of the top clinical research organizations around the world. We have highlighted their strengths and core service offerings to make it easier for you to find the right fit clinical research partner.

In addition, we’ve put together a list of 9 fundamental questions to ask the prospective clinical research organization , which will help you to save time and ensure a right fit in picking the CRO.

Formerly known as Quintiles and IMS Health, IQVIA is one of the largest CROs in the world, with a large range of service offerings to help advance clinical research.

The company was founded in North Carolina in 1982, and has since grown to over 88,000 employees in more than 100 countries.

Some clinical trial solutions offered by IQVIA include:

• Assistance with protocol design
• Design of phase 1 clinical trials
• Assessment and improvement of phase 2 and 3 clinical trials
• Site identification & selection
• Patient recruitment
• Access to global laboratories via their wholly owned subsidiary Q2 Solutions

Parexel is a global clinical research organization that was founded in 1982, and specializes in conducting clinical studies on behalf of its pharmaceutical partners in order to accelerate and ensure the drug approval process of up-and-coming potential treatments. It currently operates in more than 50 countries, and is run by more than 18,000 employees around the world.

The company has a wide range of service offerings, covering nearly every type of clinical trial service to assist sponsors in running successful clinical studies.

Some clinical trial solutions offered by Parexel include:

• Clinical trial design and development for early phase, phase 2 & 3, and late phase clinical trials
• Clinical data management
• Decentralized clinical trials
• Clinical supply chain management
• Medical writing
• Regulatory affairs consulting
• Pharmacovigilance

3. PRA Health Sciences

PRA Health Sciences is one of the largest contract research organizations in the world. Founded in 1976 under the name “Anti-Inflammatory Drug Study Group”, the company was renamed to PRA in 1982. PRA Health Sciences employees more than 17,000 people, and provides coverage to more than 90 countries.

In 2021, PRA Health Sciences was acquired by the Ireland-headquartered global CRO leader ICON, which is also reviewed in this list.

Some clinical trial solutions offered by PRA Health Sciences include:

• Decentralized Clinical Trials Platform
• Protocol Consultation & Study Design
• Onsite Support services
• Customized Solutions for Biotech (such as asset valuation, regulatory strategy, engagement and support, drug development strategy and funding solutions)
• Clinical Diagnostics
• Site Commercial Solutions
• PRA’s Laboratories for Drug Development

Headquartered in Ireland, ICON was founded in 1990 in Dublin by co-founders John Climax and Ronan Lambre. The company has since grown to be one of the largest CROs in the world. As of September 2020, the company employs more than 15,000 people in 94 locations and across 40 countries.

ICON offers clinical research services which include consulting, clinical development and commercialization across a wide range of therapeutic areas.

In 2021, ICON acquired PRA Health Sciences, which is another CRO and global leader in clinical research services.

Some clinical trial solutions offered by ICON:

• Commercial Positioning
• Early Phase
• Functional Services Provision
• Laboratories
• Language Services
• Medical Imaging
• Real World Intelligence
• Site & Patient Solutions
• COVID-19 Clinical Operations

5. Syneos Health

Formerly known as InVentiv Health Incorporated and INC Research, Syneos Health is a publicly listed and global contract research organization. The company is based in Morrisville, North Carolina, and specializes in assisting companies with late-stage clinical trials. Syneos Health currently employs more than 25,000 people, and has offices across 91 locations.

In early 2018, INC Research was acquired inVentiv Health, and the merged company was named Syneos Health.

Some clinical trial solutions offered by Syneos Health include:

• Decentralized Clinical Trials Solutions
• Bioanalytical Solutions
• Phase II-III/Phase IIIb-IIIV
• Medical Device Diagnostics
• Clinical Data Management
• Clinical Project Management
• Clinical Monitoring
• Drug Safety & Pharmacovigilance
• Site and Patient Access

6. Labcorp Drug Development (Formerly Covance)

Formerly known as Covance and renamed to Labcorp Drug Development in early 2021, this CRO is one of the largest contract research organizations in the world. The company claims to provide the world’s largest central laboratory network, and has been rated as one of the best places to work for LGBTQ+ equality by the Human Rights Campaign organization in 2018 to 2021. Currently, Labcorp employs over 70,000 people and is able to support clinical research efforts in almost 100 countries around the world.

Some clinical trial solutions offered by Labcorp Drug Development include:

• Preclinical Services
• Clinical Trials
• Clinical Trial Laboratory Services
• Post-Marketing Solutions
• Medical Devices
• Data & Technology

Also known as Pharmaceutical Product Development, PPD is a large global contract research organization headquartered in Wilmington, North Carolina. Started as a one-person consulting firm in 1985, PPD has grown to over 27,000 employees worldwide, and provides a wide range of clinical research services to pharmaceutical and biotech companies.

Some clinical trial solutions offered by PPD include:

• Clinical Development
• Early Development
• Peri- and Post-Approval
• PPD Biotech
• PPD Laboratories
• Product Development and Consulting
• Site and Patient Centric Solutions

8. Fisher Clinical Services

Part of Thermo Fisher Scientific, Fisher Clinical Services is a global clinical research organization with headquarters in Center Valley, Philadelphia.

The company has been in the business of clinical supply chain management for over 20 years, and is focused exclusively on working with the packaging and distribution requirements of clinical trials across the globe.

Some clinical trial solutions offered by Fisher Clinical Services include:

• Biologistics Management
• Cell & Gene Therapy
• Clinical Ancillary Management
• Clinical Label Services
• Clinical Trial Packaging & Storage
• Clinical Supply Optimization Services
• Cold Chain Management & Expertise
• Direct-to-Patient
• Distribution & Logistics
• Strategic Comparator Sourcing
• Public Health Research

Established in 1997 under the name Kiecana Clinical Research, KCR is a full-service contract research organization that provides a variety of services for clinical monitoring, safety & pharmacovigilance, clinical project management, quality assurance and regulatory affairs.

KCR operates globally, and has offices in North America, Western Europe, Central Europe and Eartern Europe. The company currently employs more than 700 staff.

Some clinical trial solutions offered by KCR include:

• Trial Execution

10. Medpace

Founded in 1992 and based in Cincinnati, Ohio, Medpace is a midsize clinical contract research organization. The company has operations in over 45 countries, and employs over 2,800 people. Medpace provides support services for Phase I-IV clinical trials for pharmaceutical and biotechnology companies, which include central laboratory services and regulatory services.

Some clinical trial solutions offered by Medpace include:

• Biostatistics and Data Sciences
• Clinical Trial Management
• Drug Safety and Pharmacovigilance
• Medical Writing
• Quality Assurance
• Regulatory Affairs
• Risk-Based Monitoring
• Medpace Laboratories

11. Clintec

Now in business for over 22 years, Clintec is a medium-sized global contract research organization for pharmaceutical, biotech and medical device industries, with large expertise in oncology and rare diseases.

The company provides the flexibility and agility of a smaller-sized CRO, while also having a wide global coverage that large CRO companies are known for. Clintec is based in more than 50 countries, and was acquired by the leading global CRO IQVIA in late 2018.

Some clinical trial solutions offered by Clintec include:

• Project Management
• Data Management
• Biostatistics
• Global Feasibilities
• Patient Recruitment & Retention

12. Worldwide Clinical Trials

Bringing over 30 years of experience to the clinical research market, Worldwide Clinical Trials is a leading medium-sized global contract research organization. Founded by physicians with a dedication and commitment to advancing medical research, Worldwide Clinical Trials was the first customer-centric CRO.

Currently the company has coverage in more than 60 countries, and has extensive experience in a wide range of therapeutic areas, including central nervous system, metabolic, cardiovascular, oncology, rare diseases and general medicine.

Some clinical trial solutions offered by Worldwide Clinical Trials include:

• Bioanalytical Lab
• Early Phase Development
• Clinical Phase IIB-II Clinical Trials
• Phase IIIB-IV Clinical Trials
• Trial Management Technologies

Named #1 CRO in the world for operational excellence at the 2021 CRO Leadership Awards, CTI Clinical Trial And Consulting Services is a medium-sized global contract research organization that has been serving pharmaceutical companies since 1999.

Based in Covington, Kentucky, CTI has offices around the world in more than 60 countries, with coverage in North America, Europe, Latin America, Middle-East, Africa, and Asia-Pacific regions.

Some clinical trial solutions offered by CTI include:

• Feasibility
• Regulatory Affairs Study Start-Up
• Medical Monitoring
• Safety & Pharmacovigilance
• Clinical Services

14. Wuxi AppTec

Founded in 2000 as WuXi PharmaTech in the city of Wuxi, China, Wuxi AppTec has grown from a single laboratory into a leading global contract research organization with more than 28,000 employees, including 23,000 scientists and more than 30 research & development and manufacturing sites around the world.

With offices in Asia, U.S, Europe and the Middle East, the company is able to provide coverage to more than 30 countries around the world.

Some clinical trial solutions offered by Wuxi AppTec include:

• Small Molecule Drug R&D and Manufacturing
• Cell Therapy and Gene Therapy
• Drug R&D and Medical Device Testing
• Clinical Services (Phase I-IV)

15. Advanced Clinical

Founded in 1994 and based out of Deerfield, Illinois, Advanced Clinical is a midsize and full-service CRO that helps sponsors with running clinical trials. The company employs more than 700 staff, and offers a wide variety of services across many therapeutic areas. Advanced Clinical has global representation in over 50 countries around the world.

Some clinical trial solutions offered by Advanced Clinical include:

• eTMF & Document Management
• Global Medical Services
• Quality & Validation

16. Pharm-Olam

Pharm-Olam is a leading midsize CRO with global headquarters located in Houston, Texas and its European headquarters in Bracknell, United Kingdom. The company employs more than 800 staff, and has 25 offices around the world, with a global coverage in more than 60 countries.

The company has therapeutic expertise in 5 areas, including Rare & Orphan Disease, Infectious Disease & Vaccine, Oncology-Hematology, Allergy and Autoimmune.

Some clinical trial solutions offered by Pharm-Olam include:

• Study Feasibility
• Site Activation
• Patient Recruitment
• Medical Affairs
• Compliance & Training
• Clinical Monitoring & Operations

17. Clinipace

Founded in 2003 and based out of Morrisville, North Carolina, Clinipace is a global midsize full-service CRO with a focus on solution customization for clinical trials. The company has a large global coverage in more than 50 countries, and has offices in North America, South America, Europe and Asia-Pacific regions.

Clinipace’s therapeutic focus areas include Oncology, Nephrology and Urology, Rare Disease, Gastroenterology and Women’s Health. The company also has complete therapeutic expertise in Infectious Disease & Vaccines, Cardiology, CNS, Immunology, and Respiratory.

Some clinical trial solutions offered by Clinipace include:

• Clinical Analytics
• Clinical Technology and Ecosystem
• Functional Service Partnership (FSP)
• Regulatory & Strategic Product Development

9 Fundamental Questions To Ask A Top CRO Company Before Signing The Contract

1. which services does the cro provide.

CROs offload a lot of operational tasks from trial sponsors, which can touch any component of clinical trial operations. From formulating an overall study strategy and implementing technologies to support the operational processes of the trial, to picking and identifying sites, and supporting patients during the trial, the range of clinical services offered by a CRO tends to be vast and inclusive of all the typical services and support you will require for running a successful clinical trial.

However, not all CROs are the same in their service offerings, or are able to offer the same depth of capability within a seemingly same clinical trial support process. For this reason it is important to understand exactly which kind of clinical services and support you are looking to receive from the prospective CRO when running your clinical trial.

While services such as clinical monitoring and clinical trial management are offered by the majority of CROs, the specific needs of each trial are unique, and for this reason it is important to first identify what will be the unique services your trial requires. Completing this internal analysis first will help you to understand the extent to which a potential CRO partner will be able to provide all of these services.

Some CROs specialize in specific clinical trial functions which the company may label as a “core services”, in which case this is a sign the company will have more expertise, experience, and will be set up in a way to maximize their capabilities in providing support for these services compared to other services that the CRO offers.

For example, a CRO may include patient recruitment as part of its “core services”, which implies that they are highly skilled in and have the necessary infrastructure to design and implement a high-quality patient recruitment strategy.

Clara Health CRO Support Services: At Clara Health our specialty services include technology-augmented digital and patient advocacy recruitment, as well as patient support via our signature patient recruitment platform, which we use to upgrade clinical trials and deliver results sponsors look for in their recruitment and retention campaigns.

At Clara, we work alongside CROs to supplement and support clinical trials with modern and personalized capabilities that CROs do not typically have the bandwidth, corporate structure or infrastructure to support.

If you would like to learn more about exactly how our platform can upgrade your unique trial, feel free to book a Free 30 Minute Consultation Session Here with one of our in-house experts.

2. What Related Experience Does The CRO Have?

It is helpful to ask the prospective CRO company if they have any relevant experience in running clinical trials that would be an asset in designing and running your study. Previous experience in a related therapeutic area or in running a trial with a similar design allows CROs to have a deeper understanding into potential opportunities and challenges, increasing the likelihood of your clinical study being successful.

For example, if a sponsor is planning to run a trial in oncology, for the purpose of site identification and selection it would be valuable to partner with a CRO vendor that has expertise in this area, as they likely already have a good understanding of which sites will lead to optimal results.

However, it is also important to consider all factors when selecting a CRO vendor and not to rely on therapeutic experience as the sole qualifier for whether or not a potential CRO is a fit for your trial. While previous experience is beneficial, some sponsors close themselves off from working with vendors that have not worked in their therapeutic area, which significantly limits options when choosing a CRO partner that is truly a good fit for their clinical study.

This can impact the end result of your clinical study, as sponsors that are not successful in choosing a CRO vendor that is the right overall fit may face difficulties if the needs of their clinical study aren’t being properly met.

Clara Health: We have worked to provide support for clinical trials across a wide range of therapeutic areas and trial designs. Our specialty is filling in the gaps that CROs traditionally did not have to think about, which include digital patient recruitment, patient advocacy recruitment, and technology-augmented patient support.

Additionally, we are constantly building our proprietary data and running tests in a variety of therapeutic areas. These research efforts allow us to have a detailed understanding of the expected level of difficulty when recruiting particular patient populations, as well as allow us to predict with accuracy which segments of the targeted population will be likely to qualify in a particular study.

3. What Are The Communication Workflows & Expectations For Performing And Delivering Contracted Services?

It is important that you clarify what the expectations for communication will be between your prospective CRO vendor and your internal teams, as you will most likely be working with the CRO of your choice for the entire duration of your clinical trial.

There are a vast variety of factors and success determinants for a clinical trial, which are continuously undergoing change as the study unfolds. For this reason, it is recommended that you work with a CRO that is proactive in their communication, so that you are kept up to date with information about important changes as your clinical trial progresses.

A vendor that is proactive rather than reactive in their communication and approach to dealing with arising issues is one of the most important qualities in CRO. Challenging situations will naturally arise, and the promptness with which they are taken care of will significantly impact your clinical trial’s degree of success. Therefore, seeking a vendor that is able to match the standard of communication that you as a sponsor would like to experience throughout the duration of your partnership is one of the most critical steps in determining which CRO is the right fit for your clinical trial.

We’ve included a few additional questions pertaining to the communication structure and reporting expectations that you can ask a prospective CRO vendor to determine the degree of fit in this particular category:

Communication Expectations:

• If we were to move forward with you, which of your team members will be our main point of contact?
• How available will you be outside of the scheduled meetings to address any of our concerns or additional requests?
• What will be the frequency at which update meetings will be conducted, and who will be present at those meetings?
• Which clinical study processes will be reported on, and what will be the workflow for how we will receive this information?
• What will be the cadence at which we will receive progress reports?
• Would we be able to access metrics electronically via an interactive dashboard, or will you send us formal reports?

Clara Health: At Clara Health, we directly interact and actively work with several key stakeholders involved in running a clinical trial, which includes sponsors, CROs, sites, and patients. This unique position allows us to have a centralized perspective which helps us to see all the moving parts of a clinical trial at the same time, which helps to identify issues and relay this vital information and insight back to the sponsor (or other appropriate stakeholders) in the shortest time possible.

The ability to access this perspective allows us to gather the most accurate, complete, and up-to-date information about how the clinical trial is unfolding, and quickly becomes very valuable to sponsors for their clinical trial.

As an example, we may receive feedback from patients about having an unsatisfactory experience with a particular study site. We are able to aggregate and analyze this information, and relay our findings back to the sponsor and the study site to improve the experience for other patients.

4. What Is The CRO’s Client Satisfaction Record?

It is a good practice to request information or metrics from the prospective CRO vendor that can point to the degree of satisfaction of their past clients. Prior to signing the contract, vendors will naturally do their best to uplift their image and future value to you during their sales conversations with you and your team. It can be tricky to get an objective understanding of what the partnership experience will actually entail, especially when there are multiple vendors fighting for your commitment.

We recommend that you ask the prospective vendor to provide success metrics regarding areas of clinical trial operations that are going to be important for your trial.

For example, you may be interested in learning about the vendor’s relationship to finances, in which case it will be useful to ask them about situations in which they went over the planned budget, and investigate into the reasons behind that. Alternatively you may be concerned about potential delays in timelines, in which case it would be helpful to learn about metrics regarding the CRO’s ability to meet timeline expectations.

You may also request to talk to the prospective CRO’s past clients, which will help you to gain insight into what the relationship was like and give you the opportunity to examine if the way in which the particular CRO manages its relationships and performs its services meets the expectations that you would have for your potential relationship and for your clinical trial.

Clara Health: At Clara Health, our relationships with our partners and with our patients are most important to us. In the unique position where we fit in the clinical trial process, we have the opportunity to directly co-create the clinical trial patient experience with a variety of stakeholders, including sponsors, sites, CROs, and patients.

Our company’s values and culture have been directed and developed to be such that the client and patient experience is at the top of priority for all of our internal teams, and we work to provide the best quality of care to all stakeholders.

We have many testimonials from every type of partner we’ve worked with which we can happily share with you.

5. How Do You Adapt When Encountering Challenges With Running A Clinical Trial?

It is inevitable that challenges and unforeseen changes will arise throughout the operational clinical trial process, and for this reason it is important to work with a CRO vendor that can provide you with evidence of their flexibility and ability to adapt to sudden changes.

The ideal CRO partner is one that is highly consultative throughout the entire process, and has an ability and the initiative to deal with challenges at their seed stage, prior to them turning into major obstacles for the success of your trial.

CROs naturally have a large reach, and there are a lot of different clinical trial mechanisms and processes that are under their control. They are able to monitor and respond to what is going on in every key link in the chain of the clinical trial operation.

It is reasonable to expect this level of oversight from a CRO, and additional questions that can help you gain insight into this include:

• What are some examples where the CRO was effective at monitoring the health of clinical trials they’ve helped operate in the past?
• How quickly does the CRO respond to challenges or opportunities for improving the clinical trial experience?
• How well does the CRO gather & process information from study sites, study teams, patients & the sponsor, and what are their typical data analysis workflows?

It is also recommended to speak to the prospective CROs past clients to help you gain insight into how well they respond and adapt to the naturally arising challenges in clinical trials.

Clara Health: While CROs do have a large reach within the clinical trial, no CRO has complete visibility into every clinical process. They are not typically set up to support full visibility, which can manifest as a potential threat to your clinical trial as it unfolds. This is especially true for parts of the clinical trial processes that CROs naturally do not specialize and often subcontract, such as clinical trial recruitment.

At Clara, we are in a unique position in relation to other key partners involved in operating the clinical trial. We are in direct and frequent contact with patients, CROs, study sites, study teams, and the sponsor, and have a very deep understanding of the patient pipeline. This allows us the unique ability to go very deep into specific parts of the recruitment chain and investigate what is working and what is not working.

In addition, Clara functions as a resource for all partners in the clinical trial. For example, we work directly with site teams to ensure that they have access to a 3rd party that they can relay their needs to and receive fast support in case there is anything they require that can improve the patient recruitment process.

6. Which Parts Of Operating The Clinical Trial Will You Be Outsourcing?

Since there are so many processes and mechanisms that go into operating a clinical trial, CROs will always outsource some parts of running and managing the study. While you can expect that the prospective CRO will subcontract some of the work, it is important to find out which exact parts the clinical study will be outsourced.

There are certain basic and key clinical processes (such as site selection) that CROs almost always help with, and if you find that these parts of your trial are going to be subcontracted to another company, it is recommended to find out why the CROs operations are set up this way and how this would impact the service you will receive.

Ultimately what matters to you as a partner and client is that the quality of service and care that you will receive will be up to standard, and meet what was promised and what you are expecting. While this trust is important after you have signed the contract, it is recommended that prior to entering into such a significant commitment that you have evidence and the conviction that the CRO of your choice is truly the right fit and will deliver the quality of service that was being discussed.

Since it is impossible to predict exactly what the quality of this relationship and services performed will actually be like in practice, it is recommended that you understand the details of what will be done for your trial and how. Investigating how the CRO outsources and subcontracts services for a clinical trial will help you to gain necessary insight that you would need to make the correct vendor selection decision.

Clara Health: At Clara, we maximize the effectiveness of the digital component across the entire digital & recruitment spectrum, which is added on top of the existing capabilities of the CROs and other vendors involved in operating your clinical trial. In addition, we offer services that augment the CROs efforts, which has the potential to significantly improve the patient experience, operations flows, recruitment and retention performance, which is so important in ensuring the success of a clinical trial.

For example, if a CRO wants to have a great site relationship, we are able to come in as a third party on behalf of the sponsor and CRO and act as a resource and additional support for sites.

In another example, If a sponsor wants to have great relationships with the patient community, Clara is able to come in on behalf of the sponsor and develop these relationships while being perceived more neutrally by the patient community.

7. Do You Have Experience Running International Trials?

If you are planning on operating an international clinical trial, it is recommended to work with a CRO that has extensive experience in this area. While many CROs will offer near-global coverage, the level of experience with specific geographic locations can significantly vary from one vendor to another.

It is important to work with a CRO that has experience running clinical trials in the specific countries and regions you are planning to conduct your research in. Being compliant with the local rules and regulations for clinical testing is a very complex process that requires existing understanding and familiarity in order to ensure logistical smoothness and to mitigate legal risks. In operating a clinical trial, there are a multitude of clinical services and processes, which can greatly vary across the many regions in which you can conduct clinical testing.

A CRO that is lacking experience in operating international trials or operating in particular regions where you plan on conducting research may not be able to meet your desired quality and agility expectations, and therefore may not be the right fit for your international clinical trial.

Clara Health: In the past, we have provided international patient recruitment and digitally-augmented trial support services for clinical trials in the EU, Canada, UK, Australia and South America.

Clara Health is fully compliant to operate international studies everywhere in the world, with the exception of Russia and China.

8. What Is Your Relationship With Patients?

Patient-centric approach to designing and operating a clinical trial is becoming more and more crucial in the clinical research space. The ability of a sponsor and their CRO partner to understand the needs and characteristics of their target patient community is a significant determinant of whether or not the study will be a success.

A sponsor that has close and authentic relationships with the patient community tends to have a deeper understanding of how to create the best clinical trial experience that will attract patients and keep their interest throughout the clinical trial.

In addition, strong relationships with patients allow sponsors and CROs to forecast recruitment and patient retention pipeline with much higher accuracy. This ability is critical for ensuring the success of the trial and mitigating the risk of low enrollment. After an understanding of the patient population is acquired, sponsors gain the necessary insight to design a clinical trial that is not only favorable to their research results, but is also practical and will result in the enrollment numbers they are looking for.

While many CROs have already recognized the importance of patient-centricity and evolved the ways in which they design and operate clinical trials, other CROs have not yet made such a pivot in their values. It is important to understand the degree of importance the prospective CRO places on creating a favorable patient experience, and what kind of infrastructure the company has to support it.

At Clara, we recommend choosing a CRO partner that is adapting to the patient-centric model which is becoming more and more important for running a successful clinical trial.

Clara Health: Since early stages of our development, we’ve had a dedicated patient advocacy team that has been integral in shaping our company’s vision and operations. We have built our entire platform and recruitment infrastructure around creating the best experience for patients. Our teams, corporate values, service offerings and company infrastructure all work in the service of the patient.

In addition, over the many years of being in business we have heavily invested in building authentic patient community relationships that span across a variety of therapeutic areas. This has given us a unique ability to receive feedback directly from patients that is genuine and authentic around marketing materials, strategy for patient recruitment, and other services that we build for specific trials.

This ability to build partnerships with the patient community in an authentic way gives us a very unique ability to engage with the patient community on behalf of a pharmaceutical company, allowing our sponsor & CRO partners the opportunity to start conversations with patients through our in-house patient advocacy team.

If you would like to learn how Clara can help you to build a strong & authentic relationship with your target patient community, get in touch with us and we’d be happy to share our capabilities and previous results with you as they relate to your current or upcoming clinical trial.

9. How Is The CRO Going To Utilize Patient Input For Developing The Trial?

In the initial stages of clinical trial design, sponsors often determine the ideal patient profiles that would help them to drive the most favorable research outcomes for their study. While it is important for the success of your trial to determine who your ideal patients are, very often these projections do not match up with what is viable in practice.

At Clara, we often encounter study protocols that are not set up realistically for successful recruitment to be possible.

Common mistakes that are made when determining trial eligibility criteria and trial design include:

• Overestimating the interest in the clinical trial from the target patient population
• A lack of patient focus in the trial design
• A lack of convenience for patients in their participation
• Complicated and/or inefficient study experience flows
• Crafting the eligibility criteria around the patient population that is most likely to lead to favorable study outcomes, without conducting sufficient research to more accurately estimate the recruitment and retention difficulty of the group for a particular study

It is natural for there to be a “push & pull” between the research ideal and the real world practicality. It is important to determine the correct balance between these two sides for your trial, as going too far in either direction will decrease the chance of your clinical study’s success.

The nature of the industry as it is right now is such that there is excess research idealization and not enough emphasis on patient centricity. This distorted orientation has resulted in many clinical trials being unsuccessful, negatively impacting sponsors, patients and the entire clinical trials industry.

The ideal CRO partner should help you make sure that your protocol design sets your study up for success. The CRO should be able to help you determine the proper balance between the research ideal and the real world practicality, and back up their findings with sufficient research and patient data that can project your trial being a success.

Clara Health: When formulating a recruitment and retention plan for our clients, we begin with conducting thorough research into the target trial patient population. This allows us to get a clear understanding of which recruitment channels will yield the best results and what kind of marketing materials will resonate with the prospective study participants.

To ensure accuracy and real-world applicability of our research, we consult and collaborate with our internal patient advocacy and patient support teams, as well as with our clients and patients representing the target trial patient profiles. We then tie our findings back with any existing proprietary data that we have in connection with the therapeutic area or the prospective target patient group.

Our unique position within the clinical recruitment chain gives us the presence and deep-rooted access needed to effectively tap into any of the three patient traffic sources: digital recruitment, offline recruitment, or patient advocacy recruitment.

Once a recruitment campaign has gone live, we constantly monitor, analyze and optimize our performance to make sure that the processes we have in place are as efficient as possible and drive the greatest results. In addition, we have the capability to layer in any traditional advertising (such as billboard ads) if requested by the study sponsor.

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Clinical Researcher

Leave No Site Behind: How Sites, Sponsors, and CROs Can Speed Clinical Research Together

Clinical Researcher January 14, 2020

Clinical Researcher—January 2020 (Volume 34, Issue 1)

SITE STRATEGIES

As the age of blockbuster drugs has given way to precise, impactful treatments that are customized for rare diseases and individual patients, the volume of clinical trials has compounded. In 2007, there were 48,290 clinical trials recorded worldwide while more than 322,100 trials are expected to be tallied for 2019.{1}

With clinical studies flourishing, sponsors have shifted to an outsourcing model to drive greater efficiency. More than 70% of all clinical trials are expected to involve a contract research organization (CRO) in 2020,{2} and analysts predict the CRO market will reach nearly $55 billion by 2025.{3}

Clinical research sites are also becoming increasingly vital in helping sponsors and CROs keep pace with bringing new treatments to market. Sites, however, face significant hurdles in meeting the demands of this new era of drug innovation—hurdles that may discourage the all-important participation of principal investigators in studies. In fact, more than half of first-time investigators do not conduct a subsequent trial.{4}

Going forward, there is a significant opportunity for the industry to improve collaboration and execution of clinical trials. Sites have the most to gain, especially with improving productivity and reducing delays that impact trial execution. Recently, leading investigators from a range of different sites identified three key opportunities for improvement: communication and collaboration, information sharing, and streamlining common trial processes.

Improve Communication and Collaboration to Drive Productivity

Good communication often starts with mutual understanding. By getting to know one another and establishing common ground, clinical trial partners can be more productive and develop stronger working relationships. While the ability of sponsors and CROs to meet the needs of sites has progressed in recent years, most sites say there is room to improve communication,{5} especially around the day-to-day responsibilities and workloads that impact timelines at sites.

“Sponsors don’t have visibility into the many things on my plate to understand that their timelines are sometimes not achievable,” said Katie Seehusen, a regulatory specialist with the Iowa Diabetes & Endocrinology Research Center . “I am the only regulatory specialist at my site, and we currently have 30 ongoing drug and device studies with seven new studies coming soon. So, it’s important that I structure my time to get everything done.”

Seehusen frequently balances the critical deadlines of various sponsors and CROs, and ultimately has to make difficult judgement calls about which jobs get done first based on priorities and available resources. “I am pretty good at multitasking,” she said, “but sometimes there just isn’t enough time in the day. Just because we work at high volume, doesn’t mean we have a high volume of staff.”

The demand on sites to get more done, faster can be overwhelming. Sites acknowledge that better communication on timelines and even collaborating with sponsors and CROs on how to work more efficiently can alleviate some of the pressure they’re feeling.

Jeff Kingsley, CEO of IACT Health , a clinical research network based in Columbus, Ga., said part of the communication and collaboration breakdown often stems from the outsourcing model itself. “There’s sometimes a big gap between the sponsor and clinical trial sites with separate companies handling labs, oversight, and so forth,” he said. “If sites and sponsors become more strongly connected, we could better support the tremendous growth happening throughout the industry. Bridging the communication gap is critical to this.”

Streamline Information Exchange for Faster Trials

One of the most common needs among researchers is improving information exchange with sponsors and CROs.{6} Key drivers included reducing manual processes, improving collaboration among study partners, and better visibility and oversight (see Figure 1).

Figure 1: Top Drivers to Streamline Information Exchange

Sites often depend on sponsors and CROs to provide technology for managing trial activities and collaborating during a study. Sponsors and CROs on average use three different systems—including e-mail, portals, file sharing, and eTMF applications—to exchange trial data and documents with study partners.

Meanwhile, sites support multiple studies at one time. With each sponsor providing a unique system to sites running dozens or even hundreds of trials, the use of technology can become overwhelming. In fact, the average site uses a minimum of 12 different electronic systems to collect and capture clinical study data.{7}

“One of the biggest challenges we have as a site is that most technology comes from sponsors, and the sponsors select the technology that serves their needs,” said Rachel Sheppard, clinical research director for the Clinical Trials Units at the University of Louisville . “We’re running trials for hundreds of sponsors, so we have to learn all those various systems and be agile in them. So, it’s been difficult for us to transition to electronic regulatory systems because of that.”

Several sites noted that better information sharing could be addressed by newer cloud-based tools that are capable of streamlining trial activities and accelerating research.{8} Sheppard said that administrative minutiae are holding sites back and preventing trials from getting started quickly. “These setbacks could be resolved with better technology,” she added.

Nelson Rutrick, CEO of Adams Clinical , a site outside Boston specializing in psychiatric research, said sponsors collect large amounts of information on site data quality during patient enrollment. Making these data available helps sites understand where they’re doing well and where they need to improve.

“Sites know how well they are doing relative to other sites on recruitment metrics, but they often lack visibility into their performance on quality metrics,” Rutrick said. “Most electronic data capture and eSource products have reporting features that display some statistics to sites, but these features are usually turned off. Sponsors and CROs should turn these features on so sites can see where improvement is needed.”

Some sites also said making information sharing more efficient would enable them to focus more time and energy on other important matters—most notably training.

“I never want to be so busy that I stop learning,” said Seehusen. “Research is always changing. There are always new things to learn. We have a job where we constantly need to learn about what’s changing. I would love to have more time to train and be better at my job.”

Better training is an opportunity to improve clinical trials. Researchers want a roadmap for the right qualifications to do their job—the skills they should have and the related competencies. There’s a big movement among sites around competency-based roles. With so many specialized roles, the industry could benefit from sites having more ways to get credentialed for their unique roles.

Katrina Quidley, a regulatory manager with IACT, said she would like more sponsors and CROs to consider waiving redundant requirements for good clinical practice (GCP) training for staff with Certified Clinical Research Coordinator (CCRC) or Certified Principal Investigator (CPI) credentials through the Association of Clinical Research Professionals (ACRP). In 2014, the TransCelerate BioPharma Inc. initiative began acknowledging these ACRP certifications as an equivalent to any GCP course. Accepting ACRP certifications for GCP fulfillment streamlines the training process and allows sites to move forward with completing all personnel requirements and meeting expected timelines.

Simplify Operational Processes to Reduce Delays

With more study partners in the mix, trials have become increasingly complex. More people are involved in trial processes, each wanting to review and approve a site’s work. This often leads to trials being underbudgeted or delayed.

“There are many parties involved these days,” said Kingsley. “Innovation can stagnate because of so many in-betweens. CROs typically prefer that all communication be filtered through them, so we often lose the emotional connection with sponsors. Sponsors and sites don’t have much contact anymore.”

Seehusen said she often finds herself dealing with more people than she can count—all needing the same information. “Sponsors and CROs have a lot of people working on the trial, so there can often be a lot of redundant steps that cause delays,” she noted. “Centralizing coordination and improving organization could save me hours; and if you multiply that across all the studies happening at any given time, it could add up to days of improved productivity.”

Working Better Together to Improve Patients’ Lives

The pressure to innovate specialized products and get them to market quickly will only become harder as the ecosystem of clinical trial stakeholders continues to expand. Improving efficiency among study partners will enable the entire industry to better support the growing number of trials and, ultimately, bring innovative new therapies and drugs to market much faster for the patients who need them.

In our conversations with expert sources at sites, they underscored their desire to work with sponsors and CROs to improve trial processes. In the end, they said everyone just wants to achieve more positive results.

“Our biggest focus is on improving the lives of patients,” Seehusen said. “So, if we’re working at a capacity of maybe 15 studies a year and we can get to 20 studies a year because we’re working more efficiently and effectively, then we can see more patients and help more people. That’s really our end goal—just being able to help more people.”

• ClinicalTrials.gov. 2019. Number of Registered Studies Over Time. https://clinicaltrials.gov/ct2/resources/trends
• Business Wire. 2015. Research and Markets: The New 2015 Trends of Global Clinical Development Outsourcing Market. https://www.businesswire.com/news/home/20150130005621/en/Research-Markets-New-2015-Trends-Global-Clinical
• Grand View Research. 2019. Healthcare CRO Market Size Worth $54.7 Billion by 2025. https://www.grandviewresearch.com/press-release/global-healthcare-cro-market
• ScienceDirect. 2017. One and done: Reasons principal investigators conduct only one FDA-regulated drug trial. https://www.sciencedirect.com/science/article/pii/S245186541630093X
• CenterWatch. 2019. Sponsors, CROs Doing Better, Sites Say, But More Work Is Needed. https://www.centerwatch.com/articles/24465-sponsors-cros-doing-better-sites-say-but-more-work-is-needed
• Veeva Systems, Inc. 2019. Veeva 2019 Unified Clinical Operations Survey Report. https://www.veeva.com/resources/veeva-2019-unified-clinical-operations-survey-report/
• BioSpace. 2016. New CenterWatch Study Finds that E-Clinical Technologies are Increasing Investigative Site Work Burden and Performance Inefficiencies. https://www.biospace.com/article/releases/new-centerwatch-inc-study-finds-that-e-clinical-technologies-are-increasing-investigative-site-work-burden-and-performance-inefficiencies-/?keywords=centerwatch+study+finds+that+e-clinical
• Veeva Systems. 2019. Veeva announces free eRegulatory solution for Clinical Trial Sites. https://www.veeva.com/resources/veeva-announces-free-eregulatory-solution-for-clinical-research-sites/

Bree Burks ( [email protected] ) is Vice President, Site Strategy for Veeva Systems, with more than 12 years of experience in research in sponsor and site settings.

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ICON recognised as leading contract research organisation and employer by Scrip, Fierce Life Sciences, Financial Times and others

Icon finishes the second half of 2022 with an impressive line-up of awards that commend its healthcare intelligence work and status as an employer of choice, as independently judged by industry leaders and peers worldwide..

Dublin, Ireland – 13 December 2022 –  ICON plc , (NASDAQ: ICLR) a world-leading healthcare intelligence and clinical research organisation, has been recognised with a number of coveted business and industry awards over the second half of 2022 for delivering clinical research services, alongside specialist collaborations on data, analytics and digital healthcare.

The awards include the Best Contract Research Organisation – Full-Service Providers from Scrip, marking the second consecutive time after a win in 2021. Winners are chosen by an independent panel of industry experts, each chosen for their knowledge, objectivity and credibility.

ICON’s innovation capabilities were recognised as the company won the Data Analytics/Business Intelligence category in the Fierce Biotech Innovation Awards – Life Sciences 2022. The award was for ICON’s proprietary One Search tool, which uses intuitive, integrated workflow and artificial intelligence to provide access to multiple data sources to help identify optimum trial sites the first time.

In November, ICON was recognised in the Financial Times European Leader in Diversity 2023 Award List, ranked 80th out of 850 companies. The list is based on independent surveys of more than 100,000 employees across the continent. They were given the chance to evaluate their own employer’s diversity and inclusion practices and to give their perception of those adopted by other prominent employers in their respective industries. This follows recognition earlier in the year from Forbes as one of America’s Best Employers for Diversity for the second year running.

Overall, ICON was named on the 2022 Forbes World’s Best Employers List, which is based on a survey of 150,000 full-time and part-time workers from 57 countries.

ICON CEO Steve Cutler commented on the wide range of awards: “We are pleased to be recognised across the board by industry groups and leaders as we continue our focus on healthcare intelligence. To be recognised for innovations that drive clinical research forward, build an inclusive and diverse workplace and for strong collaboration with our customers is testament to the tireless efforts of our talented employees around the globe.” 

Additional industry awards and recognition

ICON also won a total of four gold awards at the 2022 MarCom Awards from the Association of Marketing and Communication Professionals. ICON’s Creative & Digital Services and Insight and Evidence & Value teams won a gold award in the Print Media/Marketing/Promotion/Materials category, while the Creative & Digital Services and Patient Recruitment Solutions teams won a gold award in the Digital Media/Web Video/Marketing category. Additionally, ICON’s Creative & Digital Services and Insights, Evidence & Value teams won two gold awards in the categories of Communications/Public Relations/Other – Health Equity-Multicultural and Marketing/Promotion Campaign/Branding Refresh.

Technology company Medidata awarded ICON a Collaboration of the Year award for contributions to its RAVE Imaging Platform. This accolade recognises a unique partnership aimed at delivering a flexible and high-quality imaging trial experience for sites, readers and sponsors.

In October, 33 ICON staff members won awards or were finalists in numerous categories at the PharmaTimes Clinical Researcher of the Year Americas Awards, including Experienced Contract Research Associate, Clinical Trial Manager, Global Project Manager, Start-up—Single, Start-up—Team, Global Project Team, and Global Partnership Team.

Further success for ICON in the closing months of 2022 came from wins in the Sales Promotion category and the Poster Design category at the 2022 Health + Wellness Design Awards hosted by Graphic Design USA, as well as the Established Irish Investor in Asia Award from Asia Matters.

A full list of ICON’s industry awards can be viewed at  www.iconplc.com/awards.  

About ICON plc

ICON is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022. For further information about ICON, visit: www.iconplc.com .

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Matthew geriak, investigational research pharmacist, on clinical research trends.

Matthew Geriak, Pharm.D. is an Investigational Research Pharmacist at an institution in San Diego, California, and an Adjunct Clinical Associate Professor at Touro University California. He has 22 years of experience in hospital pharmacy and 10 years’ experience as an Investigational Research Pharmacist.  He received his Pharm.D. from the University Read more

Amgen initiative to bring community practices into oncology clinical trials

www.amgen.com

About 80 percent of cancer patients in the U.S. are treated outside of an academic institute by a community oncologist. Amgen has launched Amgen Community Oncology Research Collaborators (ACORC), a new initiative that will provide community oncologists the opportunity to have their patients participate in clinical trials of investigational agents from Amgen’s pipeline. (Amgen)

Wikipedia outlines global clinical trial registration requirements

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Clinical trial registration is the practice of documenting clinical trials before they are performed, in order to combat publication bias and selective reporting. Clinical trial registration is required in some countries, and ClinicalTrials.gov (U.S.) remains the largest and most widely used online registry for clinical trials. (Wikipedia)

Cancer drugs approved via accelerated pathway may not improve survival

www.raps.org

Authors of a new study published in JAMA Internal Medicine research found that just one-fifth of confirmatory trials for cancer drug indications approved via FDA’s accelerated approval pathway demonstrated improvements in overall survival (OS).  Although improvement in surrogate measures may be acceptable for accelerated approval, confirmatory trials should verify the clinical benefits in terms of overall survival (OS) or quality of life. (Regulatory Focus)

Bickering over “fair market value” in clinical trial budgets

www.centerwatch.com

Coming up with a fair market value for a clinical trial budget that both sponsors and sites can agree on is difficult, as not everyone agrees what “fair market value” is.  Some argue that the sites should focus on providing a solid defense for each expensive they expect a sponsor to foot; we should use the term “defendable market value” instead of “fair market value.” (CenterWatch)

Talking to your clinical trial data

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Until recently, analyzing the amount of information generated in a clinical trial required labor-intensive, resource-consuming effort.  A new advance in clinical development is the use of artificial intelligence (AI)-informed virtual assistants that allow us to “speak” to our data and get rapid insights, which allows us to correct our course before trial delays occur. (Clinical Leader)

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A Comprehensive Guide to Clinical Research Organizations (CROs)

Clinical Research Organizations (CROs) play a crucial role in the pharmaceutical, biotechnology, and medical device industries. They provide support to companies in the form of research services outsourced on a contract basis. In this comprehensive guide, we will explore what CROs are, who their clients are, the stages of the research process they are typically involved in, and delve into the exciting career opportunities within the field of clinical research.

Table of Contents

Introduction to Clinical Research Organizations (CROs)  The Role of CROs in the Research Process  Services Offered by CROs  Clients and Partners of CROs  Careers in Clinical Research  Clinical Research Associate (CRA) Roles and Responsibilities  Educational and Professional Requirements for Clinical Research  Careers Advancement Opportunities in Clinical Research  Tips for Success in Clinical Research  Careers Resources and Professional Organizations  Conclusion

Introduction to Clinical Research Organizations (CROs)

Clinical Research Organizations (CROs) are companies that provide support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. They offer a wide range of services , including biopharmaceutical development, clinical development, clinical trials management, and pharmacovigilance. CROs aim to simplify the entry into drug markets and streamline the drug development process by providing specialized expertise and resources.

The Role of CROs in the Research Process

CROs play a crucial role in the research process, from the early stages of drug discovery and development to the final stages of clinical trials and commercialization. They work closely with their clients to design and execute clinical trials, ensuring adherence to regulatory requirements and ethical standards. CROs also provide support in data management, statistical analysis, and the preparation of regulatory submissions.

Services Offered by CROs

CROs offer a wide range of services to their clients, including but not limited to: 

Biopharmaceutical development : CROs assist in the development of new drugs, from preclinical studies to early-phase clinical trials. Clinical development: CROs design and manage clinical trials, ensuring compliance with regulatory requirements and ethical standards. 

Clinical trials management: CROs oversee all aspects of clinical trials, including site selection, patient recruitment, data collection, and safety monitoring. 

Pharmacovigilance : CROs monitor the safety of drugs and medical devices during clinical trials and after they are on the market. 

Real-world evidence and outcomes research : CROs collect and analyze data from real-world sources, such as electronic health records, to generate evidence on the safety and effectiveness of drugs and medical devices. CROs conduct studies to evaluate the effectiveness and safety of drugs and medical devices in real-world settings. 

Clients and Partners of CROs

CROs work with a diverse range of clients, including pharmaceutical  companies,  biotechnology firms, medical device manufacturers, research institutions, and government organizations . They collaborate closely with their clients to ensure that research studies are conducted efficiently, safely, and in compliance with regulatory requirements. CROs also partner with academic institutions and foundations to support their research initiatives.

Careers in Clinical Research

Clinical research offers exciting career opportunities for individuals interested in the scientific, regulatory, and operational aspects of drug development. 

Careers in clinical research span a wide range of roles, including Clinical Research Associate (CRA), Clinical Project Manager, Data Manager, Biostatistician, and Medical Writer, among others. These roles require a combination of scientific knowledge, attention to detail, critical thinking, and strong communication skills.

Clinical Research Associate (CRA) Roles and Responsibilities

Clinical Research Associates (CRAs) play a crucial role in the execution and monitoring of clinical trials. Their responsibilities include site selection and initiation, monitoring study progress, ensuring compliance with protocols and regulatory requirements, and maintaining accurate and complete documentation. CRAs work closely with investigators, study coordinators, and other stakeholders to ensure that trials are conducted safely and efficiently.

Educational and Professional Requirements for Clinical Research Careers

Careers in clinical research typically require a strong educational background in life sciences or a related field. Many positions, such as CRAs, require a bachelor's or master's degree in a scientific discipline. Professional certifications, such as the Certified Clinical Research Associate (CCRA) certification, can enhance career prospects and demonstrate expertise in the field.

Advancement Opportunities in Clinical Research

Clinical research offers ample opportunities for career advancement and professional growth. Experienced professionals can progress to more senior roles, such as Clinical Project Manager or Clinical Operations Director, where they oversee the planning and execution of multiple clinical trials. Continuing education, networking, and staying updated with industry trends are essential for career advancement in clinical research.

Tips for success in seeking a Career in Clinical Research

To succeed in clinical research careers, professionals should continuously develop their scientific knowledge, stay updated with regulatory requirements, and enhance their communication and project management skills. Networking, building relationships with key stakeholders, and seeking mentorship can also contribute to career advancement in the field.

Resources and Professional Organizations for Clinical Research Professionals

Several resources and professional organizations cater to the needs of clinical research professionals. These include industry publications, online forums, conferences, and professional associations. Organizations such as the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SoCRA) provide educational resources, networking opportunities, and professional certifications for clinical research professionals.

Clinical Research Organizations (CROs) play a vital role in the pharmaceutical, biotechnology, and medical device industries by providing research services on a contract basis. They offer a wide range of services to support the development and execution of clinical trials, ensuring compliance with regulatory requirements and ethical standards. 

Careers in clinical research offer exciting opportunities for individuals interested in the scientific, regulatory, and operational aspects of drug development. By partnering with CROs and pursuing careers in clinical research, professionals can contribute to the advancement of medical science and the development of innovative therapies.

If you're interested in exploring careers opportunities in clinical research, view our current vacancies at ICON today.

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Galera Therapeutics Settles Clinical Trial Dispute Lawsuit

Galera Therapeutics ( GRTX ) just unveiled an announcement.

Galera Therapeutics, Inc. recently settled a lawsuit against two Clinical Research Organizations (CROs) for a sum of $975,000. The dispute centered around a 2021 error in a pivotal Phase 3 cancer trial, which prompted allegations of contract breach and negligence from Galera. With the settlement, both parties have released each other from further obligations and plan to formally conclude the litigation by August 2024.

For detailed information about GRTX stock, go to TipRanks’ Stock Analysis page .

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Circuit clinical and mercer allergy & pulmonary associates forge new community-based research partnership.

BUFFALO, N.Y. , Aug. 6, 2024 /PRNewswire/ --  Circuit Clinical , a community-based research organization, and Mercer Allergy & Pulmonary Associates , a premier allergy and pulmonary care provider, are pleased to announce a strategic partnership to bring advanced medical solutions to Hamilton Township, New Jersey patients through cutting-edge clinical trials.

This collaboration significantly advances community-based access to groundbreaking treatments and therapies through clinical trials in central New Jersey . By leveraging Circuit Clinical's extensive expertise in conducting clinical research and Mercer Allergy & Pulmonary Associates' commitment to exceptional patient care, this partnership promises to enhance the scope and quality of medical services available to Mercer's patients and the surrounding population through an embedded traditional clinical trial model.

"We are thrilled to be working side-by-side with Mercer Allergy & Pulmonary Associates. Their dedication to top-tier care aligns perfectly with our mission to change how people participate in clinical research. We can now provide Mercer patients new treatment options that could significantly impact their quality of life in the same location where they receive their current care," expressed Margaret Scott , Senior Vice President of Clinical Operations at Circuit Clinical.

Mercer Allergy & Pulmonary Associates, known for its comprehensive approach to managing allergic and pulmonary conditions, will now offer its patients the newest treatment options through research trials. This initiative will enable patients to participate in clinical studies that explore the efficacy of new therapies and treatments, ultimately contributing to the advancement of medical science. Including diverse and underrepresented participants from the surrounding community and Mercer's patients will impact research and the industry's persistent challenges of clinical trial recruitment.

Dr. Anthony J. Ricketti , Founder and Lead Physician at Mercer Allergy & Pulmonary Associates, shared, "Our commitment to providing high-quality care is at the core of everything we do. We are excited to offer our patients new and potentially life-changing treatments by partnering with Circuit Clinical. This collaboration underscores our dedication to managing existing conditions and exploring innovative solutions to improve patient outcomes."

Circuit Clinical's role will involve coordinating and managing the clinical trials. At the same time, Mercer Allergy & Pulmonary Associates will integrate these opportunities into their practice, ensuring patients are aware of the latest advancements in medical care.

For more information about the clinical trials offered through this new partnership, please visit circuitclinical.com .

About Circuit Clinical Circuit Clinical empowers patients to choose clinical research as a care option through improved access to clinical trials. Dedicated to transforming the experience of finding, choosing, and participating in clinical research for physicians and their patients, Circuit provides clinical research services through traditional, hybrid, and decentralized community-based site models and their MD Prescreen service that optimizes patient referrals. Follow on  LinkedIn  for updates and announcements.

About Mercer Allergy & Pulmonary Associates Mercer Allergy & Pulmonary Associates is a premier specialized allergy and pulmonary care provider based in Hamilton, NJ . The practice provides dedicated patient-centered care to improve health outcomes through advanced diagnostic and treatment options. The expert physicians and staff team are committed to delivering compassionate and effective care for various allergy and pulmonary conditions.

Media Contacts: Circuit Clinical Candice Kent VP of Marketing and Communications 484-885-0981

View original content to download multimedia: https://www.prnewswire.com/news-releases/circuit-clinical-and-mercer-allergy--pulmonary-associates-forge-new-community-based-research-partnership-302215510.html

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Bruker acquires stake in NovAliX, an alliance to revolutionize drug discovery

08-Aug-2024 - Last updated on 08-Aug-2024 at 09:32 GMT

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As part of this alliance, Bruker has acquired a minority stake in NovAliX, and says this highlights the increasing importance of CROs in the rapidly

evolving pharmaceutical industry.

The collaboration aims to harness the combined strengths of NovAliX’s expertise in structural biology, biophysics, and pharmacology with Bruker’s  analytical technology. Together, the two companies plan to advance drug discovery and development processes, increasing the likelihood of success in an industry where bringing new drugs to market is more challenging and costly than ever.

“Bruker is at the forefront of technology serving the life sciences and focuses on the best ways to deploy technology for the advancement of science,” said Stephan Jenn, president of NovAliX.

“For more than 20 years, NovAliX has independently developed an unrivaled research engine. Now, our alliance with Bruker marks a crucial step in further enhancing the research capacity we offer for our biopharmaceutical customers' therapeutic projects.”

Founding the biophysics Institute for Biomedical Research (IBRB)

A key element of this strategic partnership is the establishment of the Biophysics Institute for Biomedical Research (IBRB), a new institution that will

bring together NovAliX, Bruker, and the renowned Max Planck Institute. This collaborative environment is set to provide scientists from both academia and industry with access to state-of-the-art biophysics instrumentation and drug discovery expertise, fostering the development of next-generation therapeutic technologies.

The IBRB is designed to facilitate collaboration and innovation, enabling new therapeutic ideas to mature through shared access to cutting-edge facilities and expertise. This unique combination of resources is expected to generate the experimental data crucial for the success of current and future drug discovery programs.

Expanding footprint and global reach

As part of this strategic move, NovAliX is also planning to establish new scientific and technology platforms to expand its presence in the United States, further enhancing its capabilities and reach in the global drug discovery market.

“IBRB will significantly contribute to the ongoing transformation of this industry,” said Denis Zeyer, CEO of NovAliX. “By fostering interaction between stakeholders and organizing access to shared knowledge through the joint use of major facilities, IBRB will enable new therapeutic innovation to mature effectively.”

A new era of drug discovery

This alliance between a giant drug discovery CRO and a leading scientific instrument provider marks a pivotal moment in the field of therapeutic innovation. Historically dominated by large pharmaceutical companies and biotech firms, the industry is now witnessing the rise of a new model—one where collaborations like that of NovAliX and Bruker are driving the next wave of drug discovery and development.

As the partnership unfolds, the biopharmaceutical industry can expect to see an acceleration in the incubation, deployment, and support for advanced biophysical methods, ultimately leading to more efficient and successful therapeutic discoveries.

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The rise of clinical research

Sunday, 04 Aug 2024

Huge potential: The economic value of the global clinical trial market stood at over RM368bil last year, with a projected growth of 6.5% annually. — 123rf

WHEN you think about industries with big potential for growth in Malaysia, chances are you will not immediately think about the clinical research industry.

However, as reported in May, the industry has brought in RM1.38bil in cumulative gross national income since 2012 for the country, with over 2,450 clinical trials conducted. And we stand to benefit further from the significant economic value of the global clinical trial market, which stood at over US$80bil (RM368bil) last year, with a projected growth of 6.5% annually.

It is no surprise then that Prime Minister Datuk Seri Anwar Ibrahim has expressed intentions to prioritise efforts to make the country a regional hub for clinical research.

As he pointed out, last year saw an encouraging growth in the industry in Malaysia with a 24% increase in global clinical trials compared with 2022.

Malaysia’s clinical research ambitions got a further boost in a July study on country readiness for global clinical trials, which put Malaysia at the top among South-East Asian countries.

The study, published by pharmaceutical data and testing solutions provider IQVIA, shows Malaysia also ranked 28th globally, with Indonesia being the only other South-East Asian country in the top 30. The top three countries were the United States, Germany, and Japan.

The rankings were based on country scores in three key metrics: patient availability, clinical infrastructure, and operating infrastructure, which are further split into sub-metrics.

This spotlight on the country’s conducive environment for clinical trials is good news for Malaysia, indicating that we are on the right track in expanding the industry.

Long time coming

Malaysia actually started focusing on expanding this industry slightly over a decade ago with the establishment of Clinical Research Malaysia (CRM) under the Health Ministry in 2012.

As a one-stop centre for clinical research support in the country, CRM has tried to make as conducive an environment as possible for clinical research to attract more investors and sponsors. In Malaysia, these global clinical trials are often multinational trials wholly sponsored by pharmaceutical organisations, biotech companies, and medical devices companies.

Back in 2015, CRM used Malaysia’s diverse population as one of our main selling points to potential investors of clinical research, but its chief executive officer, Dr Akhmal Yusof, says they have since had to switch their strategy with the evolving global demographic.

“That [a multiracial population] is the same value proposition in Australia, Singapore, and even in the United States now, so we have to create a new value proposition, and that is to deliver clinical research with speed, reliability, and quality.

“That’s why we need ease of business, people who are trained well, building professionalism,” Dr Akhmal says to Sunday Star.

One of the things CRM focused on was hastening the application and approval process by revamping it.

In 2012, the average time taken from when a sponsor expressed interest to the start of the clinical trial was about 350 days, almost a year.

CRM, along with the cooperation of relevant authorities, has since managed to reduce the application timeline to about three months.

Meanwhile, among the measures CRM has undertaken to increase the number of skilled workers ready to take on roles in clinical research, is establishing a Centre of Excellence – opened by Health Minister Datuk Seri Dr Dzulkefly Ahmad last month – to train young graduates in clinical research, says Dr Akhmal.

The government is also looking to venture more into early- phase first-in-human (FIH) trials, as currently, the majority of the clinical trials conducted in Malaysia are of the Phase II and III variety.

FIH trials are a type of clinical trial in which a new drug, procedure or treatment is tested in humans for the first time, after undergoing tests in laboratory and animal studies.

Phase II trials determine efficacy and further evaluate safety; Phase III confirms efficacy, monitors side effects, compares with standard or similar interventions, and collects information about safety, according to the US National Institutes of Health (see graphic, right).

Since the start of this year, the clinical research industry in Malaysia appears to have accelerated its growth in economic value.

“From 2022 going into 2023, the number was about RM133mil. The point I want to make is that up to June this year, we see an escalation number of RM210mil. This is not a number coming from one sector but coming from the Health Ministry, the private sector, and also academia,” says Dr Akhmal.

In January, Swiss healthcare giant Roche Pharmaceuticals picked Sarawak General Hospital as its global FIH clinical trial site, making Malaysia the seventh country included by Roche in the study and the first within the Asia-Pacific region.

Roche has invested around RM190mil in clinical trials in Malaysia since 2012.

The path forward

While Malaysia has done a lot to improve the clinical research industry over the years, there is still more that can be done to realise its full potential.

Looking forward, CRM has come up with its next 10-year plan, setting several key performance indicators (KPI) as part of its 2033 goal.

Among the KPIs set were to hit a target of 80 Phase I trials, reach RM2.1bil in clinical research gross national income, create 4,000 skilled jobs in clinical research, and get 3,500 new sponsored research projects.

CRM acknowledges that more can be done to improve the ease of business and in offering more incentives such as tax breaks to lure more investors to the country.

Revolutionising the electronic medical record system in the country would also speed up operational processes such as screening for patients with suitable profiles for the requirements of clinical trials.

However, some of these things are beyond the scope of CRM’s authority.

Then there’s the issue of consistent manpower. Due to the high demand for skilled clinical research workers, a number of those trained through CRM programmes end up leaving for the private sector.

Meanwhile, in the IQVIA study, Malaysia’s highest score was in patient availability, which measured sub-metrics such as population, healthcare access and quality index, and number of physicians, among others.

But this may be undermined by the lack of knowledge among the populace about clinical trials.

For one, many misconceptions about the industry, such as the “guinea pig” myth, persist.

No test bunny

Clinical investigator based at Hospital Kuala Lumpur, Dr Muthukkumaran Thiagarajan, who specialises in oncology, concedes that the misconception he faces the most often is those who think clinical trial participants are being treated like guinea pigs.

However, he says most patients are open to the suggestion of clinical trials once they understand more about how trials are run and the benefits they stand to gain from participating in such trials.

He wants to assure the public that most of the drugs or treatments being researched in Malaysia have been extensively tested before being used on patients.

“We know a lot more about their efficacy and toxicity. Therefore, we are better able to monitor the safety of patients involved in the trial,” he says.

Participating in trials also means patients, especially in oncology, who may have exhausted every other avenue for a cure, can have access to new drugs or treatments that may not be available to them otherwise.

“Because it’s cancer, it might not be able to cure them but patients who respond well to the new treatment can get an improved quality of life,” says Dr Akhmal, adding that CRM acknowledges there is a need to raise more awareness about the safety and benefits of clinical trials to make it easier to recruit patients or healthy participants for such trials.

Mohd Zulhilmi Paiz Ismadi, a haemophilia patient, who is participating in a clinical trial for the disease, shares that he is benefiting from the new treatment being tested.

“It is easier to administer, more convenient and I foresee better compliance,” he notes, explaining that his previous treatment took up to 45 minutes a day to administer at a frequency of twice a week.

For comparison, he only needs to undergo the new treatment, under the supervision of the trial investigating team, once every two months.

However, Dr Muthukkumaran says they usually struggle more with the huge number of patients unfit to participate in trials due to advanced disease or other underlying medical conditions.

This is Part 1 of Sunday Star’s report on Malaysia’s clinical research ambitions.

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Effective health crisis management only possible with adaptive organization

by University West

During COVID-19, Sweden's ability to manage crises and production planning in health care came into focus. Neither regional management nor hospital directors had any experience with a pandemic.

Ritva Rosenbäck, in her doctoral thesis "Capacity Management in Swedish Hospitals during the COVID-19 Pandemic" at University West, researched how emergency departments, intensive care units, and inpatient care built capacity to care for COVID patients.

Rosenbäck is a chemical engineer and has worked as a manager both in industry and health care. Nowadays, she divides her time as an expert at the National Board of Health and Welfare, writing books, doing actual production planning in health care organizations, and conducting research.

"It became clear that intensive care needed the most capacity. When I started researching in November 2020, the pandemic had passed its most acute phase, and I wanted to investigate how capacity needed to be balanced daily against the various health care needs," says Rosenbäck, doctor in production technology.

The care required during the pandemic differed from the care normally provided. In a major accident, a rescue leader at the accident site calls an on-call official in the region who then distributes patients between hospitals, ensuring those who need the most care get it.

"At the beginning of the pandemic, it was the ICU Managers who were in contact with colleagues in Italy and learned about the severe situation. When patients started arriving at hospitals, the regions decided to open external ICU departments. At the hospitals, they preferred to use the surgery unit because of its familiar environment, and this was possible when planned operations had been canceled."

Prefer adaptive over rigid

The pandemic lasted a long time and the health care needs changed in waves, unlike an accident which is usually short and sudden. In the thesis, Rosenbäck could show that the decision hierarchy during the pandemic worked better if it was delegated rather than centralized. Every day new situations arose that were unfamiliar to doctors who did not know how to care for the patients. Experienced doctors said it felt like they were thrown back to their internship.

"The organization needed to be adaptive rather than rigid. They had to learn what worked and didn't know which competencies were needed when. Additionally, the pandemic came in waves, so between waves, they returned to regular care. In this strange situation, they greatly benefited from each other's work. Among other things, medical associations held webinars on Wednesdays where they shared the latest findings," says Rosenbäck.

There was a lack of initiative from the authorities in disseminating knowledge. Medical journals published articles without review to get information out as quickly as possible. It was judged that the benefits outweighed the disadvantages, even if there was no fully established evidence.

Three crucial consequences

In the study, Rosenbäck conducted both qualitative interviews and a quantitative survey, with inductive, exploratory, and deductive analysis methods. In the study, she identified three crucial needs of adaptive leadership during a prolonged event like the pandemic: how prepared the organization was, how the early phase was handled, and what resources they had in terms of materials, personnel, and facilities.

"Good crisis preparedness requires a low occupancy rate, something we don't have in Sweden today. It is difficult because low occupancy costs money. But things that can be done in preparation include making agreements on how to move staff in a crisis. The organization could also train staff in other tasks beforehand, such as ICU care."

In the early phase, it is important to gather as much information as possible and to identify who suddenly gets a heavy workload, where there is excess staff, and who needs to learn things. Those with specialized skills must stay where they are needed most and get all the capacity they need. Meetings should be frequent but short, and preferably digital.

"You should not have a rigid plan, you should have a plan to make a plan, because you don't know what you need," says Rosenbäck.

Lessons for the future

Could the pandemic have been handled differently, given the conditions?

"It would obviously have been good to understand earlier that even health care staff infected each other, but there was a need to save on protective equipment. The organizations could have been quicker to train the category of staff that had too little to do. They learned as time went on, and learning turned out to be a key factor along with positive storytelling.

"If the staff who moved to the ICU, for example, could return to their department with an okay picture, it motivated others to move."

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