A Contract Research Organization (CRO) is a company that provides support services to the pharmaceutical, biotechnology, and medical device industries, typically on an outsourced, contractual basis. CROs manage the complex and time-consuming tasks associated with Drug Discovery and Clinical Development, allowing the sponsoring company (the pharmaceutical client) to focus on its core competencies like basic research and therapeutic innovation.
CRO services span the entire development lifecycle, including pre-clinical testing, regulatory submission support, clinical trial management, data management, and Pharmacovigilance. Specifically, in clinical trials, CROs manage site selection, patient recruitment, clinical monitoring (ensuring adherence to GCP), biostatistics, and medical writing for final reports. The outsourcing model allows sponsors to access global expertise, quickly scale operations, and reduce fixed costs, making CROs an indispensable partner in accelerating the time-to-market for new medicines in the highly regulated life sciences environment.
