Contract research organizations, also referred to as clinical research organizations, or CROs, provide a wide range of outsourced pharmaceutical research services to the pharmaceutical and biotech industry to aid in the drug and medical device research and development process.
Services offered by CROs include product development and formulation, clinical trial management (from pre-clinical through phase IV), central laboratory services for processing trial samples, data management services for preparation of a FDA New Drug Application or an Abbreviated New Drug Application, and other complementary services.
Despite continued consolidation in the industry, it is estimated that there are over 1,100 CROs worldwide. The key growth drivers of the CRO industry are: 1) the increasing complexity of clinical trials, which require more time and staff, 2) an increasing amount of data required from clinical trials for regulatory review that must be managed effectively, and 3) the multinational and multi-center nature of current clinical trials.