QAI supports the conduct of clinical studies for regulatory compliance as third-party Quality Assurance auditors under FDA/ICH Good Clinical Practices.   QAI provides the independent review of clinical studies to improve the quality of the reports submitted to FDA.

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

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

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

  • Gap Analysis
  • Coordinator and Principal Investigator Training
  • 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.