Constant Clinical Trial oversight is being performed in order to ensure the protection of research participants and integrity of the data collected, to assure compliance with the protocol and applicable regulatory requirements. Critical elements include adherence to informed consent procedures, inclusion and exclusion requirements, adequate and timely safety reporting and monitoring, adherence to protocol mandated investigations and follow-up, and the review of regulatory documents. Our experienced clinical team performs quality compliance visits, focused site visits, accompanied and co-monitoring visits to review CRA and site performance, assess the qualification of investigators, identify missing or inconsistent data and potential protocol violations, analyze site characteristics (e.g., high screen failure or protocol deviation rates, low rate or no reported Adverse Events, delays in reporting data), managing noncompliance, including developing specific processes for investigating suspected fraud, inspect site documentation and examine Investigational Medical Product (IMP)/Medical Device (MD) storage, accessibility and accounting.
