CRO (Contract Research Organization)

A contract research organization (CRO) is a company that assists pharmaceutical and medical device manufacturers with research services on a contract basis.

The services provided may be niche, limited to specializing biostatistical advice, management of regulatory affairs, or pharmacovigilance, or may provide a full range of services for clinical trial management from the selection of clinical sites and investigators, to supporting patient recruitment, safety surveillance, clinical monitoring, site audits, project management, data management, and biostatistics. CROs also help support research institutions, universities, and government organizations.

 

CROs provide a resource to the biotech industry for expertise in running clinical trials, streamlining the process, and increasing the speed at which new medications, devices, and technology are brought to market. CROs are also subject to regulations governing clinical research and are similarly audited by regulatory authorities.

Source: Beach, J. E. (2001). Clinical trials integrity: A CRO perspective. Accountability in Research, 8(3), 245–260. https://doi.org/10.1080/08989620108573977