Endpoint Adjudication Committees

Endpoint Adjudication Committee Assessments 
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.

Our eAdjudication® Software Helps Ensure That Committee Assessments
Are as “Accurate and Free of Bias as Possible” 
- Provided Quickly and Efficiently

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

Starting with study teams and data managers, easy access to the eAdjudication® platform through a standard web browser encourages compliance with standardized data reporting - and mobile access.

Even before committee members become involved, the eAdjudication® software supports manages their engagement by establishing reviewers’ qualifications and training levels, then allowing the assigningment of the appropriate events to members. Committee members then employ user-friendly Adjudication Forms to facilitate efficient assessment. The eAdjudication process proceeds quickly and efficiently, aided by excellent data visualization, real-time updates and action alerts – all tracked in a clear audit trail. Adjudication coordinators shepherd the entire process with a real-time smart-reporting page that issues alerts when recorded events await submission for adjudication, or assessments are pending, or more data is requested by reviewers. The system also queues consensus meetings for events on which adjudication reviewers disagree. The eAdjudication® software platform leaves nothing to chance.

Request a Demo of the eAdjudication® Software Solution

Download Ethical eAdjudication for Endpoint Adjudication Dossier

eAdjudication
software solution
service description

DOWNLOAD
Previous Next

DOWNLOAD the Endpoint Adjudication Charter Template. By the "Endpoint Adjudication" Linkedin Group 

In order to shed light on endpoint adjudication, the LinkedIn Endpoint Adjudication Community generated an Events Charter Template for endpoint adjudication to assist those in need of guidance.

READ MORE

What are the Peculiarities to be considered when adopting a software solution for Clinical Endpoints Adjudication?

Clinical Events Committees (CEC) are routinely called upon to adjudicate complex endpoints in clinical trials.

READ MORE

Endpoint Adjudication: a new focused Professional Community is Now on Linkedin with more than 500 Members

Clinical Events Independent Assessment and Adjudication is crucial for reducing patients’ risks and bias related with multi center studies with subjective or image-based endpoints.

READ MORE