Clinical research organization

The Clinical Research Organization (CRO) is in clinical trial the independent organization that is responsible for the Data Management (DM) and the communication between medical sponsors (pharmaceutical producer), the cordinating 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 all the data exchange runs directly via Intranet and the patient data is controlled centrally by the CRO.