Endpoint Adjudication

Trionfo Research offers a dedicated global endpoint adjudication team that provides end-to-end services, including study development, set-up, and study close. Utilizing a validated web-based endpoint management system, we manage endpoint adjudication activities to the highest scientific and operational standards.

Endpoint Adjudication:

Specializing in cardiovascular, renal, and metabolic endpoints, our team has extensive experience managing the review of endpoints across various trials, from smaller outcomes trials to large global registration studies. Our team includes medically trained professionals for leadership and medical oversight, as well as specialized operational staff to ensure optimal study execution for effective endpoint collection and adjudication.
Trionfo Research has established endpoint adjudication committees comprising industry-leading professors across various therapeutic areas. These adjudicators, located at top institutions globally, have significant experience in adjudicating clinical endpoints and often chair endpoint adjudication committees.
Our endpoint adjudication team offers a range of services, including:

  • Selection, appointment, and management of the Endpoint Adjudication Committee and Chair
  • Development of endpoint definitions, the endpoint adjudication charter, voting forms, and all associated documents required for the Endpoint Adjudication Committee
  • Processes and documentation for the project workflow
  • Web-based adjudication system customized to suit trial requirements and sponsor needs
  • Training for all stakeholders
  • Collection, tracking, and processing of endpoints
  • Reporting process metrics and adjudication outcomes to the sponsor

Our preferred endpoint management system is IBM Clinical Development, a dedicated, web-based, commercial endpoint management system that is CFR 21 Part 11 compliant. This system offers an efficient, paperless approach to endpoint adjudication, centralizing all endpoint documentation, tracking changes, and managing new information. It allows us to closely monitor the endpoint adjudication workflow and ensures timely delivery of adjudication results.
Trionfo Research is committed to aligning with best industry practices, implementing quality control activities across adjudication projects, and closely monitoring projects to enable continuous improvement, ensuring projects are of the highest quality and delivered efficiently.