clinical development

Triligent’s cost effective clinical development programs meet the highest standards of the pharmaceutical, biotech and device industries, and comply with 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 worked with many US and international sponsors, ranging in size from small early stage development companies, to large international pharmaceutical, device and biotech institutions, Triligent has successfully developed numerous outstanding clinical programs to the great satisfaction of its clients.

Triligent distinguishes itself from other CROs by offering highly trained and experienced personnel 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 professionals 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 professionals 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).

Our team members 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 clinical development 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 closely with its clients to develop a high quality clinical development program that is custom tailored to meet the needs of the client in terms of results, timing and cost, while being sure to maintain careful adherence to applicable local, national and international 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.

The combined experience and expertise of the Triligent team ensures that every phase of your clinical development program is designed and conducted to maximize results while minimizing risk, time and cost.

 

clinical development
  Triligent provides a full range of clinical
development services, including:
  • Strategic Development Plans
  • Phase I, II, III & IV Protocol Design
    and Implementation
  • Study Document Preparation
  • Investigator Meetings
  • Vendor Qualification
  • Data Management Consulting
  • Sponsor / FDA Liaison
  • Training Programs