NAMSA provides expert clinical auditing services to medical device manufacturers and corporate and financial investors. With nearly 20 years of experience in the clinical research services and trial consulting business, we have a firm understanding of what constitutes quality clinical data and quality clinical data collection—from both regulatory and investment perspectives.

And according to investment banks, quality clinical data is the number one driver of company value. We help acquisitive investors evaluate company value, minimize risk, and proceed with confidence.

Common Clinical Auditing Assignments for Manufacturers

  • Gap analysis of clinical SOPs
  • Development of clinical SOPs
  • Clinical data audits
  • Pre-FDA bioresearch monitoring (BIMO) inspection audits
  • Investigative site audits
  • Data management audits
  • Preparation and support for FDA site inspection

Common Clinical Auditing Assignments (M&A Due Diligence) for Financial and Strategic Investors

  • Confirmation of clinical data suitability for FDA submission
  • Expert opinion on statistical conclusions
  • Evaluation of clinical procedures (SOPs) for conformance to regulations
  • Evaluation of clinical practices (IRB documentation, patient consent, investigator contracts, etc.)
  • Verification of data throughout data management process