Third-Party GCP Auditors

QAI supports the conduct of clinical studies for regulatory compliance as third-party Quality Assurance auditors under FDA/ICH Good Clinical Practices.  Unlike the nonclinical Good Laboratory Practices, the Good Clinical Practices do not require as much Quality Assurance oversight of studies.  QAI provides the independent review of clinical studies to improve the quality of the report submitted to FDA.

QAI operates on behalf of the sponsor, or the CRO, providing the following services:

• CRO/Vendor Qualification
• IRB Audit
• Protocol Review
• CRF Development and Design
• Source Documents Review
• Investigators Brochure (IB) Audit
• Database Audit
• Bioanalytical Data and Report Audits
• Trial Master File Review
• Clinical Reports Audits
• IND Submission Verification
• NDA Submission Verification
  

Occasionally, QAI operates on behalf of individual clinical sites, offering the following services:

• Site Qualification
• Site Audit
• Coordinator and Principal Investigator Training
• Institution and IRB Audits
• Pharmacy Audit
• Clinical Laboratory Audit

And QAI’s GLP-Compliant Archives are always available for long-term archival of the clinical study data, including paper and electronic media.