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Clinical research organization - Wikipedia, the free encyclopedia

Clinical research organization

From Wikipedia, the free encyclopedia

The Clinical Research Organization (CRO), also known as a "contract research organization," is an independent organization involved in the conduct of a clinical trial. A CRO is responsible for the Data Management (DM) and the communication between medical sponsors (pharmaceutical producer), the coordinating investigators, the investigators (physicians) and the Institutional Review Board (IEC, IDMC). Its purpose is to monitor the different clinical phases I-IV and to provide Clinical Research Associates (CRAs), that do the monitoring for each clinical trial. The Clinical Research Associate is responsible for one or more the study sites of a country. The statistical data is collected and refined by the CRO for the analysis of the patient treatment or product study results. Today most data exchange runs directly via Intranet and the patient data is controlled centrally by the CRO.

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