Independent Quality Assurance

  • System and study-specific audits
  • Document audits
    • Study Protocol
    • Case Report Form (CRF)
    • Patient Information/Informed Consent Form (PI/ICF)
    • Trial Master File (TMF)
    • Clinical Study Report (CSR)
  • Database audits
  • Vendor qualification audits
  • Independent on-site audits
  • Routine, For-cause and Pre-inspection audits
  • Assessment Visits