• The US Food and Drug Administration – Consumer Safety Officers
  
• Major US Pharmaceutical Manufacturer – Senior Clinical Research Associates
  
• Independent Auditors – Having completed 100s of Sponsor, CRO, IRB and Investigator Audits
  

Our Auditing Techniques and Scope Include:

Data Trending Anchoring Informed Consent    Training Records Regulatory Documents Case Report Forms Facility Inspection Record Storage OSHA Requirements Mock FDA Audits

Assessing Monitoring Effectiveness Source Documentation Adverse Event Reporting Drug or Device Accountability Protocol Violations and Waivers Clinical Investigator Oversight IRB, Sponsor and CRO Communication Laboratory Data Collection Process Financial Disclosure Requirements Regulations and Standards Including

Audit Plan             Audit Certificate    Close-Out Discussion

Color-Coded and Graded Compliance Findings Report Recommendations for Improvement and Achieving Compliance Overall Assessment Consistent with the FDA Definitions of No Action Indicated (NAI), Voluntary Action Indicated (VAI) and Official Action Indicated (OAI)