Clinical Site Quality
System Management

Running a clinical trial requires many moving parts. Keeping your study and processes compliant to FDA standards is a critical component to a well run trial.

Compliance Team understands the necessity of a robust, comprehensive and compliance Quality Management System guiding Clinical Trial Operations and submissions. Our clinical operations experts are versed in the complexity, and the importance of, the guiding regulations which ensure new drugs come to market with the best assurances of safety and efficacy.

We provide comprehensive Quality Management System audits to identify areas which may be at risk in your clinical plan. The typical outcome of our support in this area is a full list of observations, listed in order of criticality and citing specific regulations, which may be used as a CAPA to guide remediation activities.

Our experts can assist in development and remediation of all areas of the Quality Management System, including development of SOPs and staff training.

How can we help your Clinical Operations team stay compliant to all regulations and international standards?