CEC, DSMB AND MEDICAL DEVICE VIGILANCE

CEC, DSMB AND MEDICAL DEVICE VIGILANCE

OUR NETWORK MAKES THE DIFFERENCE

DSMBs and CECs provide clinical oversight and monitoring of a trial. CERC sets up and coordinates CEC and DSMB meetings involving prominent physicians with the highest level of expertise.

Such committees are being increasingly required by the authorities to supervise (oversee) clinical trials, especially in areas of cardiovascular research. These committees provide independent oversight of study data and methodology, review adverse events and protocol deviations, and adjudicate endpoints in the case of CECs. According to the size of the trial and the needs of the sponsor, we can organize physical CEC meetings but we also have an e-CEC platform.

Since 2005, CERC has been recruiting key opinion leaders in its clinical research areas and managing their activities in a wide range of studies.

Our mission is to create committees which regulators can trust.

CERC also provides and coordinates AE/SAE and MEDDEV reporting.

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