Endpoint Adjudication

Our team consists of medical staff, to provide leadership and medical oversight, and operational staff to coordinate the endpoint collection and adjudication process. George Clinical also has well-established adjudicator panels consisting of scientific leaders from around the world who have extensive expertise in adjudicating endpoints in a range of therapeutic areas.

Endpoint Adjudication

George Clinical has a dedicated global endpoint adjudication team that delivers end-to-end services ranging from study development and set-up through to study close. Using a validated web-based endpoint management system, George Clinical manages endpoint adjudication activities to the highest scientific and operational standards.

Endpoint Adjudication Specializing in cardiovascular and renal endpoints, our endpoint adjudication team has managed the review of thousands of endpoints across a range of smaller outcomes trials to large, global, registration studies. Our team consists of medically trained staff to provide leadership and medical oversight, and specialized operational staff to ensure the study is optimally executed for effective endpoint collection and adjudication.

George Clinical has established endpoint adjudication committees of professorial industry leads across various therapeutic areas. Located at the best institutions across the globe, these adjudicators have extensive experience in adjudicating clinical endpoints, and often chair endpoint adjudication committees.

The endpoint adjudication team provides a variety of services including:

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

George Clinical’s 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 provides an efficient, paper-less approach to the endpoint adjudication process. It enables us to centralize all endpoint documentation, track changes and manage new information. It allows us to closely monitor the endpoint adjudication workflow and ensures the timely delivery of the adjudication results.

George Clinical is dedicated to aligning with best industry practice, implements quality control activities across its adjudication projects, and monitors projects closely to enable continuous improvement to ensure projects are of the highest quality and delivered efficiently.

China OCT 2018

November 2018

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George Clinical

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Profits from George Clinical support the work of The George Institute for Global Health.

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