Clinical research organization
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[edit] Contract Research Organization (CRO)
A CRO functions as a clinical research organization for a pharmaceutical company. Hence the job of clinical research is "outsourced" or "Contracted" out by the pharmaceutical company. Hence the name. The CRO in a clinical trial is the independent organization that is responsible for the Data Management (DM) and the communication between medical sponsors (pharmaceutical producer), the coordinating investigators, the investigators (physicians) and the Ethic Committee (IEC, IDMC). Its purpose is to monitor the different clinical phases I-IV and to provide CRAs (Clinical Research Associate), that do the monitoring for each clinical trial. The CRA 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. Changements eQueries are solved by e-Mail writing and electronic CRFs (eCRF, electronic Case Report Form) of each single patient.
