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Clinical Research Organization (CRO)

The Clinical Research Organization (CRO) facilitates and conducts clinical trials in compliance with ICH and GCP guidelines. It has the personnel to formulate protocols, be responsible for all regulatory submissions including IRB and FDA, initiate investigations at different study sites, take responsibility for overseeing compliance, submit regularly to Data Safety Moderating Boards (DSMBs), organize event adjudication, prepare data for DSMBs, oversee quality control and clinical site monitoring, and prepare reports and manuscripts. It also provides database construction and biostatistical support for investigators. Because the CRO Core Facility resides in the MedStar Washington Hospital Center, which has a high volume of different patient cohorts, not only can the CRO organize multi-center trials, but also can draw on the large number of patients within the MedStar Washington Hospital Center system.

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