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