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Contract Research Organization (CRO)
CRO is a company that is contracted to perform all the administrative work on a clinical trial. It recruits researchers also give them required trainings, provides them with supplies, coordinates study administration and data collection, arrange meetings, and monitors the sites for compliance with protocol. CRO ensures that the sponsor receives ‘Clean’ data from every site. CROs range from large, international full service organizations to small, niche specialty groups and can offer their clients the experience of moving a new drug or device from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services.
In the Code of Federal Regulations (CFR), the U.S. Food and Drug Administration regulations state that a CRO is "a person [i.e., a legal person, which may be a corporation] that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration
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