Clinical Trials Sponsors and Endpoint Adjudication

Challenges that Clinical Sponsors face when Managing Endpoint Adjudication Studies internally

Operations Design and Oversight, Quality Control, and Regulatory Compliance are common areas of expertise of Clinical Trial Sponsors. However, these can become a real challenge for the effective, timely and successful accomplishment of an Endpoint Adjudication Study when different players are involved, each with their own SOPs and Data Management Solutions.

How eAdjudication® supports Efficiency and Compliance of Endpoint Adjudication Studies run directly by Clinical Sponsors

eAdjudication® is much more than just a cloud-based, single-purpose, stand-alone enterprise technology platform that is easy to use and integrate. In addition, Ethical can take care of Software Configuration, Data Management, Operations Performance and Quality Process Guidance. With limited training, study teams, committee members and staff interact effectively and efficiently in a 21 CFR Part 11- and ISO 27001- compliant environment.  

Ethical’s eAdjudication® Staff and Services provide Trial Sponsors with a toolkit of professional capabilities that can be selected and assembled to suit each organizational scenario in all phases and processes associated with Endpoint Adjudication Studies: from the design of the adjudication charter to final regulatory submission.

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Adjudication Charter, Study and SOPs Design

Software Validation, Quality Management, and Control

CEC Panel Selection, Training, and Oversight

Study Operations Management and Monitoring

Data and Documents Integration, Traking and Exports

Study Outcomes Reporting for Staff and Management

Study Closure and Data Submission Packages