Quality Assurance Audits

Early audits can identify systematic problems in the conduct of a clinical or device trial. Corrective actions will immediately contribute to project management success. External audits offer more guarantees for independence from a company’s procedures and operational units.

 

 

Our Goal:

 

Our auditing goal is to protect human subjects while achieving clinical or device trial efficacy objectives and product safety. We accomplish this through systems-based audits that focus on proactively identifying the risks and non-compliance that compromise patient safety, product efficacy, and regulatory requirements. We independently assess your compliance level while also providing valuable recommendations for improvement.

 

Our Auditing Services include 3 areas:

 

  • Independent  GCP Audits for Investigator sites:
    • Informed Consent   
    • Training Records
    • Regulatory Documents
    • Case Report Forms
    • Source Documentation
    • Adverse Event Reporting
    • Drug or Device Accountability
    • Protocol Violations and Waivers
    • Clinical Investigator Oversight
    • Facility Inspection
    • Record Storage

  • Trial Master File (TMF) Audits of Trial Sites and/or Sponsors:
    • Compliance with the standards of Good Clinical Practice (ICH-GCP, Chapter 8)
    • Compliance with National Regulations

  • Audits of investigator sites’ operating procedures and activities