international audits

Triligent has developed its pre-clinical and clinical, Phase I, Phase II, Phase III, Phase IV, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) auditing programs, to meet the highest standards of the pharmaceutical, biotech and device industries, and to comply with and exceed the requirements of the Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) guidelines, and applicable local and national laws, rules, guidelines and regulations.

Having conducted thousands of audits for more than seventy-five sponsors in over than fifty countries, Triligent auditors deliver outstanding results on time and on budget.

Triligent distinguishes itself from other CROs by offering highly trained auditors that understand the intricacies of the research process regardless of the disease state being studied. We provide our clients with seasoned professionals, most with more than 15 years experience in their fields. Our auditors have gained their many years of experience from within the FDA, contract research organizations, and various US and international pharmaceutical, device and biotech companies. Our auditors also regularly attend continuing education programs and participate as panel members in and chairs of internationally recognized seminars related to current US and international trends in GCP, GMP, and/or GLP.

Our auditors are located around the US and throughout the world. Based upon the client’s requirements, we identify members of our team who will best serve the client’s auditing needs and ask such personnel to volunteer for the project. Triligent has found that employing experienced and willing personnel on a project results in such personnel remaining on the job through to the end of the project, dedicated to providing the client with excellence and consistency in their services.

Triligent works both with its clients’ auditing Standard Operating Procedures (SOPs), as well as its own SOPs, to be sure that all auditing results meet the needs of the client as well as comply with all applicable laws, rules, guidelines and regulations. The end result of Triligent’s efforts has been a highly stable operation producing outstanding results for our clients proved by Triligent’s high rate of repeat business.

international audits
  Triligent's complete offering of
outstanding auditing services include:
  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)
  • Good Manufacturing Practice (GMP)
  • For Cause
  • Data / 21 CFR Part 11
  • Vendor
  • Institutional Review Board (IRB)
    / Ethics Committee (EC)
  • Gap Analysis
  • Software Vendor
  • Pre-Approval Inspections
  • Training