Clinical and Quality Systems support

Clinical site Audits


Auditing of clinical study sites towards preparation for FDA BIMO audits, including:


  • Regulatory Documentation review
  • Institutional Review Board (IRB) Review
  • Informed Consent and Individual Subject Issues
  • Adverse Event (SAE/AE) Reporting
  • Product Accountability
  • Protocol Deviations
  • Source Documentation review against Case Report Forms (CRFs)