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Clinical Research Organizations and Endpoint Adjudication

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

Clinical Research Organizations (CRO) are the main providers of outsourced management for Endpoint Adjudication Studies. They possess the staff, the clinical expertise and the project management capabilities to efficiently perform all the operations and processes related to such Studies. But the most important strategic asset consolidating their leadership is the flexibility to adapt their Data Management operations and software tools to different Sponsors' Adjudication Charters and Data Environments, while maintaining control, quality, and compliance.

CRO Challenges as Endpoint Adjudication Providers

Sponsors expect CROs are usually required by Sponsor to manage Endpoint Adjudication Studies in the most effective and timely way. But the Budgetary Constraints, the strictly binding Service Level Agreements and heterogeneity of the Adjudication Charters related with such studies, are hardly constant challenging challenges to Clinical Research Organizations in their competition for Process Standardization and Optimization.

How eAdjudication® supports CROs Efficiency and Compliance in their Endpoint Adjudication Management Provisioning to Sponsors

eAdjudication® is much more than just a cloud-based, single-purpose, stand-alone enterprise technology platform that is easy to use and integrate. Ethical takes also care of Software Configuration, Systems Management, and 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 CROs with a professional combination of flexibility in adapting to different Sponsors' Requirements and Standardization in all phases and Processes associated with Endpoint Adjudication Studies: from initial mapping of the adjudication charter specifications to regulatory submission.

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Endpoint Adjudication Charter Analysis
Adjudication Charter Analysis & Features' Mapping
Adjudication Study User Requirements Specifications
U.R.S Definition and Software Validation
CEC Member Training
CEC Members Training, Oversight and Alerting
Adjudication Operations Oversight
Study Operations Oversight and Quality Control
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Data and Documents Integration Traking and Exports
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Study Outcomes Reporting to Staff and  Sponsors
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.

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Endpoint Adjudication Committees: Uppsala Clinical Research UCR provides its Feedback on eAdjudication

Uppsala Clinical Research Center (UCR), a top Academic Research Organization based in Sweden, shares its experience in using eAdjudication platform to manage the central assessment of Clinical Trial Endpoints (CEC).

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The Adjudication Coordinator Dashboard, a feature of eAdjudication is the tool that every staff member would love to have

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The Adjudication Coordinator Dashboard, a feature of eAdjudication is the tool that every staff member would love to haveREAD MORE