The Growing Role of U.S. Contract Research Organizations in Clinical Trials

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The Clinical Research Industry in the U.S.

The U.S. Contract Research Organizations Market has seen tremendous growth over the past few decades. A key driver of this growth has been the rise of contract research organizations (CROs) that provide clinical trial services to pharmaceutical, biotechnology and medical device companies. As drug development has become more complex, costly and regulated, CROs have helped life sciences companies outsource various clinical trial services and functions. This allows companies to focus on their core competencies while leveraging the specialized expertise of CROs.

The U.S. represents the largest market for CRO services globally. According to a recent report, the U.S. CRO market was valued at over $35 billion in 2020 and is projected to grow at a compound annual growth rate of 6-8% through 2026. The growth is being fueled by increasing R&D expenditures in the pharmaceutical and biotech sectors, rising drug development costs, and a greater focus on outsourcing non-core functions. Leading CROs in the country provide full clinical development and commercialization services to support drug trials across all phases.

Types of Services Offered by CROs

U.S. Contract Research Organizations offer a wide range of specialized clinical development services to pharmaceutical sponsors throughout the product lifecycle. Some of the core services include:

– Clinical Trial Management: This involves planning and overseeing the operational aspects of clinical studies including site selection/management, patient recruitment, data management, medical monitoring and regulatory compliance.

– Biostatistics and Data Management: CROs provide biostatistical expertise for clinical trial design, statistical analysis and reporting. They also manage large clinical databases and ensure data integrity.

– Clinical Monitoring: CRO clinicians monitor trial conduct at research sites to ensure safety of subjects and quality/accuracy of data collection.

– Medical Writing and Regulatory Services: These include drafting clinical study reports, regulatory documents such as INDs/IDEs/NDAs/BLAs and liaising with health authorities.

– Pharmacovigilance: CROs track product safety and monitor adverse events from clinical trials as well as during the post-marketing period.

– Commercialization Services: Some CROs also assist with marketing applications, reimbursement, health economics outcomes research and Phase IV trials.

Top U.S. CROs

A few CROs that have established a strong presence in the lucrative U.S. market include:

– IQVIA: As the world’s largest CRO, IQVIA has major operations across the U.S., Europe and Asia. It offers comprehensive services from clinical development to commercialization.

– PAREXEL International: This leading global CRO has significant presence in North America, Europe and Asia/Pacific. It excels in therapeutic expertise, complex trials and regulatory submissions.

– PPD: Headquartered in North Carolina, PPD is a large, pure-play CRO focused on providing clinical development and laboratory services and has experience in all major therapeutic areas.

– Pharmaceutical Product Development (PPD): Based in North Carolina, PPD offers integrated drug development solutions from First-In-Human to Phase IV trials as well as significant Laboratory services capabilities.

– ICON plc: With headquarters in Dublin, ICON has a strong clinical research footprint across North America, Europe, Asia and Latin America with multichannel service offerings.

– Syneos Health: Following the merger of INC Research and inVentiv Health, Syneos Health now offers a full suite of clinical and commercialization services to customers globally.

In addition, there are several small and mid-size CROs focusing on specific therapeutic areas, modalities or regions within the U.S. The U.S. contract research organization market continues to evolve at a rapid pace driven by new science, increasing R&D productivity demands and skilled talent.

 

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