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Clinical Trials Sponsors and Endpoint Adjudication

Discover why Ethical's eAdjudication® is the Sponsors' Endpoint Adjudication Management Best Fit

Pharmaceutical and Medical Devices Companies are sometimes managing their Endpoint Adjudication Studies by themselves without involving a CRO or ARO. In such cases they may decide to select the Endpoint Committee Members from their Therapeutic Area Opinion Leaders community and/or to engage their own staff for the operational part of the study. Alternatively, they can choose to delegate such roles to a specialized provider able to assist their Trial Leaders in performing their study's operations in the most effective and compliant way.

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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Endpoint Adjudication Charter Analysis
Adjudication Charter, Study and SOPs Design
Adjudication Study User Requirements Specifications
Software Validation, Quality Management, and Control
CEC Member Training
CEC Panel Selection, Training, and Oversight
Adjudication Operations Oversight
Study Operations Management and Monitoring
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Data and Documents Integration, Traking and Exports
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Study Outcomes Reporting for Staff and Management
Adjudication Study Closure and Data Submission
Study Closure and Data Submission Packages

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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.

Adjudication Charter - Download the Endpoint Adjudication Charter Template designed by the Endpoint Adjudication Group on LinkedinREAD MORE

Endpoint Adjudication: eAdjudication improved Efficiency and Quality of Actelion SERAPHIN Clinical Trial

Using an online eAdjudication portal for our SERAPHIN study endpoints assessment improved the efficiency of the data collection and the quality of our processes, allowing a timely completion of the study.

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An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals

The objective of this paper was to analyze how often adjudicated methods across efficacy and safety assessments were used in drug approvals in the EU / USA...

An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug ApprovalsREAD MORE