Central Event Adjudication

Evaluation of Clinical Events Quicker than Ever

Central Event Adjudication

Evaluation of Clinical Events Quicker than Ever

The adjudication of clinical events, which in many cases are a primary endpoint, or required for decision making during the course of a trial, is of utmost importance in clinical trials. Therefore, the results should be available in the shortest possible time.

To conduct this task, Exom uses its proprietary Clinical Event Adjudication Committee (CEC) Tool, a system that allows the sites (Principal Investigators, Sub-investigators and Site staff) to upload anonymized documents that describe and provide details concerning the outcome event.

It allows the Adjudication Committee to perform the adjudication of the events online, without the need of physical meetings or requirement to find a common time-slot for a web meeting.

For each suspected outcome event, an adjudication dossier is assembled containing clinical information, narrative, imaging and/or laboratory results and this dossier is made available for revision to CEC members. The CEC members can than adjudicate the even when it fits their schedule best, within a pre-specified timeframe. This speeds-up the entire CEC process and enables the sponsor to take profound decisions quickly.

Using the electronic central event adjudication in a study showed significant benefits:

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