eAdjudication® for Endpoint Adjudication

Software Services for any Adjudication Charter, Endpoint Category or Therapeutics Area, Operations Workflow, or Data Management Environment

eAdjudication® is a comprehensive Managed Software Service built over a single-purpose enterprise technology platform that supports every operation related to endpoint adjudication committee (CEC) management, contributing to the process best practices, quality control, and the flexibility to adapt to any scenario. eAdjudication® software integrates easily and is compatible with any EDC system. Ethical optimizes it for any study needs in any phase, for any SOPs, or to meet specific regulatory needs. And once activated, your exclusively dedicated eAdjudication® platform can be exploited and adapted to all your future trials.

Why You Need an Endpoint Adjudication Software Managed Service.  

Many Software are available in the market. They have nice features and maybe can save time. But covering Data Management for an Adjudication Study requires more than just a Software. Workflows Configuration, Assessment Forms Design, Software Validation, Integrations and Customizations, Tests, Infrastructure Monitoring and Management, Users' Training and Support imply a lot more costs that are often hidden when buying. Results are the usual never-ending timelines and exploding budgets.

Ethical eAdjudication® Software is different. Designed by a team of Clinical Data Management Experts includes the following set of software-related services and expertises that cover all the hidden costs associated with cloud software traditional models.

Ethical eAdjudication® Software Platform

The eAdjudication® software platform supports Endpoint Adjudication acting as a central hub and repository of Clinical Events, collecting medical records directly from trial sites and/or integrating into several clinical platforms, including EDC, safety databases, DICOM/PACS Clinical Imaging Databases and more.


eAdjudication® Database Study Designer

Trained Customer's Staff can create, configure and manage their endpoint studies's databases by themselves. They can, for example, replicate a study in the exact same format as a previous or ongoing study or use parts (e.g Adjudication Forms) of previous and current studies. Libraries of studies and adjudication forms can be created saving time and money.


Endpoint Adjudication Charter Configuration

Ethical staff can also take care of the studies configuration starting from the Endpoint Adjudication Charter, designing electronic adjudication forms, processes and workflows to perfectly meet your Study Requirements, Non standard Reports, Integration with EDC databases and customized Data Exports can also be implemented.


Computer Software Validation and QA Support

Ethical supports the Software Validation Processes by providing GxP software validation package documentation, and supporting quality controlled Changes Management throughout the clinical trial’s duration to submission and conclusion. 


ISO/IEC 27001 Cloud Hosting and Technical Management

The Ethical eAdjudication® platform is the solid foundation on which you can build a successful and reliable endpoint adjudication process. You receive ISO 27001-certified cloud system hosting, server management with security, monitoring, backup and business continuity - with tech support for all processes through an integrated help desk.


Staff Training and Help Desk Support 

Ethical backs the promise of the eAdjudication® all-inclusive approach by including Customer's Staff Training and/or Users' Help Desk. 24/7 available on request.


Endpoint Adjudication Operations Management

Are you looking for more than just a great software service? Thanks to our exclusive partnership with highly experienced Academic Research Organizations and Endpoint Adjudication Subject Matter Experts, Ethical can provide Operations Management as a fully integrated part of its Managed Software Service. 


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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

Managing disagreement in Endpoint Adjudication

When experts disagree, it is not always easy to know who is right or even if anyone is right. In the academic world debate and disagreement feed the science and many times new ideas emerge from debate and break barriers that seemed solid up to that point.

Managing Disagreement in Endpoint AdjudicationREAD 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