Clinical Research Organizations (CROs) provide clinical development services to the pharmaceutical, biotechnology, and medical device industries. Involved in nearly three quarters of all Phase I-III trials not conducted in-house by research sponsors, CRO professionals bring their scientific, regulatory and information management expertise to bear for the completion of timely, accurate and high-quality clinical trials. By partnering with CROs, research sponsors gain the benefits of CRO experience in the drug development process as well as their skilled workforce and resources around the world to help accelerate medical product development.

CROs focus on the unique challenges of biopharmaceutical and medical device development. They offer clients a "ready made" infrastructure of global research personnel, services, and facilities, providing a full range of services to efficiently and cost-effectively manage the clinical development process. Capitalizing on CRO capabilities allows clients to focus on their own core strengths, rather than organize, create, and administer a complete clinical trial process themselves.

Tufts Center for the Study of Drug Development found that research development projects in which CROs are greatly involved are submitted to the FDA more than 30 days closer to the projected submission date than projects with less CRO involvement. This ability to reduce project timelines while maintaining a level of quality comparable to that of research sponsors is just one of the ways CROs improve efficiencies in drug development.

CROs offer an unparalleled depth of regulatory knowledge, therapeutic expertise and integrated services around the world. Acting as true partners in the development process, they provide the kind of on-the-ground capabilities that keep pipelines moving and budgets in line. With established global procedures and the highest commitment to scientific quality and research ethics, CROs play an important role in scientific innovation and have become true partners in the development of critical new medical advances for patients around the world.

Source: January/February 2006 Impact Report published by the Tufts Center for the Study of Drug Development.