X
eAdjudication software

Endpoint Adjudication
Trusted Experts

Compliant and cost-effective online adjudication for sponsors, AROs and CROs for over 16 years.

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.

Flexible adjudication software with tailored support

eAdjudication® offers such flexibility that the software configuration and support provision are tailored to exactly match your need.

endpoint adjudication process

eAdjudication® software for endpoint adjudication

A simple, efficient, user-friendly adjudication software to connect
the key adjudication actors and manage online adjudication operations.

YOUR NEED

Endpoint Adjudication Software Needs

To save money and time optimizing the set-up of multiple adjudication studies with different charter specifications.

ETHICAL'S SOLUTION:


A distinct multi-study platform for each Ethical's customer

A Single Endpoint Adjudication Multi-Study Platform

eAdjudication® provides you with an adjudication software platform dedicated to you, physically separated from other customers. It can be configured to exactly match your Standard Procedures (SOPs) while retaining the flexibility of using it for many different studies, with their specific forms, workflows, users' roles, custom reports, and exports.

RESULT

Electronic Adjudication Result

You can match your SOPs with the flexibility required to serve different sponsors or studies. You gain all the possible economies of scale of using a single software platform for all of your studies.

KNOW MORE

YOUR NEED

Endpoint Adjudication Software Needs

To support specific processes & workflows for event management, assessment, disagreement detection and resolution.

ETHICAL'S SOLUTION


Studies are delivered already configured for any SOP and charter specification.

Endpoint Adjudication: with a single Event Repository

eAdjudication® flexible delivery model has been designed to comply with any procedures that each Sponsor decides to implement. Different algorithms for event assignment to reviewers; two, three or more levels for panel assessments; any workflow chosen for disagreement management, detection and resolution; all are efficiently handled by Ethical's engineers and delivered within short timeline.

RESULT

Electronic Adjudication Result

With a single platform, you can manage the most heterogeneous adjudication studies without training your staff on complex system configurations.

KNOW MORE

YOUR NEED

Endpoint Adjudication Software Needs

Integrate or import data into the platform, submit documents of various formats to adjudicators, receive committee members’ assessments, control disagreement rates.

ETHICAL'S SOLUTION


eAdjudication® can connect to most EDC systems

eAdjudication® can connect to most EDC systems (RAVE, OPEN CLINICA, MEDRIO, REDCap, CASTOR, ORACLE CLINICAL…), and import data from files as needed. The event package accepts most of the common formats such as WORD, PDF, DICOM and EXCEL. Submission can be automated ensuring a balanced repartition per reviewer or pair of reviewers. Quality metrics are automatically collected throughout the study duration including disagreement rates. A process is available to import “clone events” (usually 5 or 10% of total events) to be re-submitted to the panel for Intra-Variability control.

RESULT

Electronic Adjudication Result

Event preparation and processing is made easy for the sponsor team. You can report real time Quality Control metrics to your Managers and Study Sponsor without expensive data processing outside the platform.

KNOW MORE

YOUR NEED

Endpoint Adjudication Software Needs

To present packages of documents of various formats (PDF, DICOM…) to committee members, all previously redacted and readily available for review.

ETHICAL'S SOLUTION


Integrated online viewer and redaction tool for PDF and DICOM images.

Endpoint Adjudication: Event Assessment Forms

eAdjudication® is fitted with a convenient, easily accessible DICOM viewer that offers a full range of tools for visualizing and managing the images. PDFs can be redacted manually. Image metadata can be redacted either automatically or manually.

RESULT

Electronic Adjudication Result

Study Operations can start immediately after the Software delivery without complex staff trainings. Committee will deal with quality designed Adjudication Forms that can be saved and repurposed for future studies.

KNOW MORE

YOUR NEED

Endpoint Adjudication Software Needs

To collect reviewers' assessments efficiently and in compliance with the charter – Reduce training and committee members’ errors.

ETHICAL'S SOLUTION


You get the adjudication forms already configured for your study charter.

Endpoint Adjudication: Disagreement Management

Adjudication forms design, field labels, edit checks and data variables used to store the Adjudication Committee assessments are designed by the experienced Ethical's Staff to match exactly each Study Charter.

RESULT

Electronic Adjudication Result

Study operations can start immediately after the software delivery without complex staff trainings. Committee will deal with quality designed Adjudication Forms that can be saved and repurposed for future studies.

KNOW MORE

YOUR NEED

Endpoint Adjudication Software Needs

To collect event-related source medical records from sites in a timely and quality controlled manner – To track and manage queries’ resolution.

ETHICAL'S SOLUTION


Direct access for sites for uploading documents and solving queries.

Endpoint Adjudication Coordinator Dashboard

eAdjudication® provides Study Investigators with access to a dedicated area with the check-list of the medical records they need to upload. Source documents are tracked and versioned. The central staff is notified of new versions. All queries for a given site are managed, tracked and solved in a single place.

RESULT

Electronic Adjudication Result

Your staff manages sites, medical records and queries in a timely and efficient manner. You can prevent one of the most common cause of delays in study completion.

KNOW MORE

YOUR NEED

Endpoint Adjudication Software Needs

To ensure a timely and compliant execution of your adjudication studies by detecting operational bottlenecks and correcting them as fast as possible.

ETHICAL'S SOLUTION


eAdjudication® provides your staff with a dashboard dedicated to real-time oversight and reporting.

Endpoint Adjudication Quality Control

We have experience from dozens of studies and we understand the metrics that study staff need for monitoring and reporting. Events assessed, reviewers' workload, alerts for outliers and delays against operational benchmarks, events in each workflow status. Each represented by a dedicated widget that can be printed or exported. 

RESULT

Electronic Adjudication Result

Operations oversight and reporting to your managers or sponsor can't be faster and easier. All operational metrics are available in a single, customizable, view.

KNOW MORE

YOUR NEED

Endpoint Adjudication Software Needs

To provide sponsors’ data managers with needed data exports during the study and to support event data submission at the end of the study.

ETHICAL'S SOLUTION


A self-service data export function available in real time for data managers.

Endpoint Adjudication Data Exports

eAdjudication® provides data managers with real-time self service data exports. Standard Exports include CSV, XML, Excel files with audit trail, events lifecycle history, adjudication outcomes, etc. Other customized formats (e.g. SAS) are available on request. A dedicated set of data and documents, suitable for submission to Authorities, is made available at the end of each study. 

RESULT

Electronic Adjudication Result

Adjudication data are always available in real-time as soon as the study starts. The self-service export function is configured to match your specifications without complex or time-consuming operations.

KNOW MORE

Request a Demo of the eAdjudication® Software Solution

We are EU-GDPR compliant: Your Data will never be used improperly



Download Ethical eAdjudication for Endpoint Adjudication Dossier

eAdjudication
software solution
service description

DOWNLOAD
Previous Next

eAdjudication integrates new Picture Archiving and Communication System (PACS) server and DICOM viewer solutions

The new eAdjudication® DICOM solution integrates the Orthanc PACS server and a fully-equipped viewer that facilitate the acquisition, storage, transmittal and display of images [...]

Clinical Images AdjudicationREAD MORE

Ethical integrates Smart Redaction Technology to eAdjudication Platform

Redaction technology improves the functionality of eAdjudication® by allowing to selectively hide information on source and administrative documents.

Ethical integrates Smart Redaction Technology to eAdjudication SoftwareREAD MORE

New in eAdjudication®: Zoom Meetings Connector to save time and enhance GxP compliance

Ethical has upgraded eAdjudication® with an innovative Zoom connector that allows to streamline the management of endpoint adjudication meetings, and safely and conveniently file meeting recordings and transcriptions within the platform.

zoom connectorREAD MORE