PPD's clinical quality assurance (CQA) services help our clients ensure the integrity of their clinical trials. We advise clients on how to verify the integrity of scientific data and ensure adherence to protocols and international regulatory guidelines. We also help clients protect research subjects' rights and welfare.
Knowledgeable Clinical Quality Assurance Auditors
PPD's clinical quality assurance (CQA) auditors are well versed in local, national and international regulations, standards and guidelines. They have conducted quality assurance programs for clinical trials throughout the world. Our multilingual staff is composed of licensed physicians, legal experts and personnel with work experience at the U.S. Food and Drug Administration (FDA).
Variety of Clinical Quality Assurance Audits
In addition to a comprehensive internal clinical quality assurance (CQA) program, our auditors provide clinical quality assurance audit services to our clients as part of a full-service or a stand-alone project. Our thorough assessment and insightful, objective recommendations help sponsors and sites develop the most effective actions to correct and prevent issues.
Among the clinical quality assurance audits we conduct are:
- Clinical investigator site audits (routine, directed, specialized and pre-inspection audits to help sites prepare for regulatory agency reviews)
- Clinical database audits and study report reviews
- Clinical study document reviews
- System audits, in which we assess a client’s standard operating procedures (SOPs), processes and staff training programs and recommend improvements where needed
- Vendor audits, in which auditors evaluate a client's vendors to ensure they have sufficient capacity and capability to deliver quality products and services on time and in compliance with regulations