Quality Assurance Consultancy supports the conduct of clinical studies for regulatory compliance as third-party quality assurance (QA) auditors under the U.S. Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) GCP. We provide the independent review of clinical studies to improve the quality of the reports submitted to the FDA.

Quality Assurance Consultancy operates on behalf of the sponsor, or the clinical research organization (CRO), providing the following services:

  • CRO/Site Qualification
  • Case report form (CRF) Development and Design
  • Investigators Brochure (IB) Audit
  • Investigational New Drug (IND) Submission Review
  • Institutional Review Board (IRB) Audit
  • Source Documents Review
  • Database Audit
  • Bioanalytical Data and Report Audits
  • Trial Master File Review
  • Clinical Reports Audits
  • New Drug Application (NDA) Submission Review

Quality Assurance Consultancy 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
Additionally, our GLP-Compliant Archives are always available for long-term archival of the clinical study data, including paper and electronic media.