eAdjudication® Integral Solution: Our Job Is to Make Yours Easier. Step Two: An All-Inclusive service to alleviate the entire workload due to Endpoint Adjudication activities.

Ethical is partnering with worldwide renowned Academic Research Organizations and Endpoint Adjudication Subject Matter Experts to be able to assist you in every step of the Adjudication process from Adjudication Charter design to archiving of Adjudication documentation in the TMF / eTMF. We have a substantial cumulative experience from designing and managing tenths of clinical studies involving Endpoint Adjudication and are happy to put it to your service. We also systematically collect your feedback to strengthen our expertise and better serve you.

A team of highly competent Experts with hands-on experience of eAdjudication ready to help you

Adjudication Charter Design

In parallel to the Protocol development we will assist you in every step of the Endpoint Adjudication Charter development helping you avoid all known pitfalls and giving quality-by-design its full meaning

Committee Members Selection and Management

We will help you select the most competent Committee Members, verify their qualification and perform quality control on their activities. In many cases, we can even provide a full Adjudication Committee composed of highly experienced reviewers with worldwide recognition.

Medical Review, Translation. Redaction

We can perform Medical Review of safety reports and Medical Records prior to the Adjudication, Translate and Anonymize Event Package Documents, follow-up Case management and Queries resolution including Consensus Meetings scheduling and reporting.

Data Management and Statistical Support

We can help process the Adjudication data with our experienced statisticians and data managers. Finally, we will advise on which material to archive and where to classify them in the Trial Master File.

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DOWNLOAD Ethical's complete Endpoint Adjudication Charter Guide

Request your FREE copy of the Adjudication Charter Guide built by Ethical after reviewing more than 20 study charters. Adjudication charters are a key element for the setup of quality Adjudication procedures and have been developed in various formats.

Event Adjudication Charter GuideREAD MORE

Endpoint Adjudication Data for Submission to FDA and EMA - What Should Be Included? 

Are you planning to submit Endpoint Adjudication Data to the FDA or the EMA? Submitted material are not only essential for obtaining marketing authorization but also a reflection of the quality of your company’s work.

Endpoint Adjudication Data for Submission to FDA and EMA - What Should Be Included?READ MORE

Endpoint Adjudication Coordinator

The endpoint adjudication coordinator is the key person ensuring a smooth and compliant conduct of the adjudication process during a clinical trial.

Endpoint Adjudication Coordinator: Composer and ConductorREAD MORE