Quality Data...Delivered by Design™

Quality Data...Delivered by Design™

GCP Auditing

Clinical Quality Assurance Services

Our Clinical Quality Assurance team provides dual services to our clients.

Our primary service is our internal review of client projects. Our CQA team reviews all our client projects to ensure we deliver the highest quality clinical research services to you.

We also provide our CQA services to our clients for their organizations. Our CQA team provides GCP and project auditing services to our sponsors, investigator sites, IRBs and academic medical centers.

Research Dynamics has been providing GCP auditing and QA services for our clients for over 15 years. We assess the data integrity and regulatory and protocol compliance of our clients’ clinical trials so they can be assured of the quality of their clinical research efforts. When issues arise during these GCP audits, we provide recommendations to improve your systems and procedures including Corrective and Preventive Action Plans (CAPA) so these errors will not happen again.

We also review the investigator site procedures that protect research Subjects rights and welfare to ensure that patients are protected and requirements are being followed.

We also provide auditing services for IRBs to ensure their compliance to regulations as well as their internal SOPS. We will visit Investigator Sites to conduct an audit or site visit for IRBs so they can be assured of the quality of the site they are approving.

Our CQA auditors are experienced and knowledgeable in FDA requirements and Good Clinical Practices. They have audited a variety of sites and sponsors and have the expertise to uncover hidden compliance issues. Our reports are comprehensive and instructional on how to prevent future errors.

Our auditors provide audit services that are part of a full-service clinical assurance, a single clinical trial or as a single site audit.

CQA audits include:

  • Investigator Site Audits
  • Sponsor Audits
  • IRB audits
  • Vendor audits
  • Database and report audits
  • Audit pre-FDA inspection