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Endpoint Adjudication Committees

Help Ensure That Trial Data is “as Accurate and Free of Bias as Possible”

We quote the FDA’s 2017 update to “Guidance for Clinical Trial Sponsors – Establishment and Operation of Clinical Trial Data Monitoring Committees” (3.3, p 7). Although the FDA has not yet required Endpoint Adjudication (EA) for trials in all therapeutic areas, it clearly sees the value that well-executed EA committee work can provide for trials preparing for regulatory review.

How eAdjudication® Software Supports Quick and Effective Committee
Assessments as Accurate and Free of Bias as Possible

eAdjudication® software features don’t leave room for error. They are designed to detect and eliminate mistakes. 
The eAdjudication® platform supports and manages the EA process through user-friendly cloud-based services, comprehensive features and capabilities.

Tailored for study teams and data managers, easy access to the eAdjudication® platform through a standard web browser encourages compliance offering standardized data reporting and mobile access

Even before committee members become involved, eAdjudication® manages their engagement by establishing qualifications and training levels, and allowing the assignment of events to the appropriate reviewers. Committee members work with user-friendly Adjudication Forms which facilitate an efficient assessment. The eAdjudication process moves quickly and efficiently, with excellent data visualization, real-time updates and action alerts – all tracked in a clear audit trail. Adjudication coordinators oversee the entire process with a real-time smart-reporting page that triggers alerts when events await submission, assessments are pending or more data is requested by reviewers. The system also plans consensus meetings in case of disagreement.
The eAdjudication® Software leaves nothing to chance.

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