Quality Assurance

Palm Beach CRO provides high-quality and comprehensive Quality Assurance support tailored to your particular project. We ensure that all aspects of your clinical trials are in full compliance with Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) requirements. Palm Beach CRO’s Quality Assurance is independent from clinical project teams.

Quality Assurance Services include:

  • Internal Audits/Assessments:
    • Informed Consent (ICF) Audit
    • Trial Master File (TMF ) Audit
    • Database Audit
    • Clinical Study Report (CSR) Audit
    • Processes/Systems
  • External Audits/Assessments:
    • Investigator Site
    • Central Laboratory
    • Vendor/Service Providers
    • IRB
    • Facilities
  • Preparation for FDA Inspection
  • Hosting FDA Inspections – Routine & For Cause Audits