Contract research organizations (CROs) play a vital role in drug development by assuming portions of the research and development process from biopharmaceutical and medical device companies. There are hundreds of CROs operating globally, with many headquartered in the United States. The U.S. Contract Research Organizations continues growing each year as biopharma companies increasingly rely on outsourcing to expedite clinical trials and new drug applications.

Role of CROs in Drug Development

CROs allow biopharma companies to focus on core competencies like research, marketing, and manufacturing by outsourcing non-core functions. U.S. Contract Research Organization (CROs)

conduct all phases of clinical trials by recruiting patients, monitoring sites, collecting and analyzing data, and reporting results. Their services span the entire development process from preclinical research and clinical pharmacology to post-marketing surveillance. CROs employ medical doctors, scientists, data managers, and many other specialized roles needed to efficiently run clinical trials and gain regulatory approval. Using CROs accelerates time to market for new drugs by leveraging large, experienced workforces operating across hundreds of trial locations worldwide.

Continued Growth of U.S. Contract Research Organizations 

This growth is fueled by biopharma’s increasing reliance on CRO partners as trials grow in complexity involving genomic biomarkers and combination therapies. Therapeutics areas driving demand include oncology, immunology, neurology, and rare/orphan diseases with specialized trial design requirements. Large CROs continue acquiring mid-size competitors to broaden global capabilities for multi-regional trials.

Leading U.S.-Based CROs

Several U.S.-based CROs dominate the global including QuintilesIMS, PRA Health Sciences, LabCorp Drug Development, and INC Research.. LabCorp Drug Development provides clinical lab testing, biorepository, and drug development consulting. INC Research has rapidly expanded through acquisition and leverages strategic partnerships with academic institutions. Together they conduct thousands of trials yearly bringing new therapies to market faster. Consolidation is expected to continue among mid-sized CROs seeking scale and technical expertise to remain competitive.

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