Proactive Risk and Compliance Audits of Your Protocols, Procedures
and Activities
Similar to our clients, our Auditing Goal is to Protect Human Subjects while achieving Clinical
Trial Product Safety and Efficacy Objectives. We accomplish this through Quality Systems-Based
Audits (not just simple checklists) that focus on proactively identifying the risks and
non-compliance that compromise patient safety and product efficacy. Whether auditing against your
Protocols or Standard Operating Procedures, Industry Standards or Regulatory Laws, NAI
independently assesses your compliance level while also providing valuable recommendations for
improvement.
Our Auditing Experience represents the three primary sides of Compliance:
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 GCP
Audits
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)
For more information or to request an Audit, please
contact us.
