Endpoint Adjudication: reduce Times and Costs while improving Efficiency and Quality of the Endpoint Studies

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EXECUTIVE SUMMARY

Adopting the Ethical eAdjudication ® Software Service to manage the Endpoint Adjudication Studies you can improve the Efficiency and the Quality of the Assessments while allowing a Reduction in Study Time and Costs.

THE CONTEXT

Clinical Endpoints Adjudication is crucial for reducing patients’ risks and bias related with multi-center studies with subjective or image-based endpoints.

In fact, where endpoints are complex to assess, include subjective components and/or cannot be blinded, a central assessment of efficacy or safety events, made by a panel of independent experts following a blinded standardized procedure, increases accuracy, independence, and homogeneity of judgments.

THE CHALLENGE

Often Endpoint Adjudication is implemented as a Paper Process where the event documentation packages are printed and delivered to the Adjudication Committee by mail together with a paper questionnaire to be returned same way with the clinician assessment.

The result is that Adjudication Studies become a time-consuming activity and hard to be managed with GxP Quality.

In other cases, complex Document Management or Data Capture (EDC) Software Systems are adopted to support the Processes of the Endpoint Adjudication Studies.

In this case, the Architectural Complexity and Lack of Flexibility of these solutions, originally designed for other purposes, require additional efforts to implement the Adjudication Charter and to manage day-by-day operations.

THE eADJUDICATION SOLUTION

Ethical eAdjudication® Software Service is exclusively designed for Providers and Sponsors managing Endpoint Adjudication Studies

The eAdjudication Solution includes:

  • Multi-Study Software Platform with a very User-Friendly User Interface and Flexible Workflows;
  • the Adjudication Charter Configuration service for a fast delivery of new Studies;
  • the Training, Documentation and GxP Software Validation Services and  Packages;
  • the ISO 27001 Cloud Hosting and Technical Management taking care of all the Software Systems' Operations;
  • the integrated Staff / Help Desk Support service for the whole study duration.

All these Services are bundled in a single All-Inclusive Solution that reliefs the owner of all the hidden costs related with traditional software ownership.

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