Quality assurance and Compliance

PharmXL Quality assurance (QA) responsible for the conduct of periodic audit for various clinical trial processes to establish a quality management system (QMS). Our QA team audit the our internal, project site as well as vendor site audit, it include clinical report, protocol development, investigator brochure and clinical laboratory audits.Our QA team meets and discusses the client’s needs and scope of the services. Our auditor prepared a audit plan which is reviewed and approved by our client.Further, within 15 days of audit, our auditor shared a draft audit report to our client.

PharmXL provides following QA services to meet the regulatory authority compliance for clinical trials include

  • Vendor audits
  • System audits (e.g., pharmacovigilance and data base)
  • Study audits
  • Investigator site audits
  • Clinical Report Audit
  • Trial Master File audits
  • Protocol Development Audit
  • Investigator Brochure Audit
  • Clinical Laboratory Audit
  • Pre-inspection audits
  • Writing, reviewing and updating SOPs
  • Developing, reviewing and updating QMS