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
