Our independent Quality Assurance group serves our clients in two distinct ways:
- To provide a benchmark for PRA operations ensuring the highest level of service
- To provide auditing services in compliance with GCP (Good Clinical Practice), GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice) and in computer system validation and 21-CFR § 11
PRA's Quality Assurance group has performed audits for a wide range of medical indications across all phases of a clinical trial. Based in North America, Europe and Asia Pacific, our group has conducted audits on six continents. We work in close collaboration with the FDA and the EMA.
PRA's global Quality Assurance group is autonomous and independent of the personnel engaged in the direction and conduct of clinical trials.