Quality assurance is the procedure for collecting, processing, and analyzing study data that is aimed at maintaining or enhancing the data’s reliability and validity. Quality assurance includes prevention, detection, and action from the beginning of data collection through publication of the results. Monitoring is an integral part of the QA process. To that end, Triligent has developed its monitoring 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 monitored many studies for US and international sponsors, ranging in size from small early stage development companies, to large international pharmaceutical, device and biotech institutions, Triligent monitors, based throughout the US and around the world, deliver outstanding results on time and on budget.

Triligent distinguishes itself from other CROs by offering highly trained monitors 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 monitors 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 Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and/or Good Laboratory Practice (GLP).

Based upon the client’s requirements, we identify members of our team who will best serve the client’s monitoring 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’ monitoring Standard Operating Procedures (SOPs), as well as its own SOPs, to be sure that all monitoring 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.