eAdjudication® Software Features & Benefits

For eClinical Professionals Who Are Tired of Pointless Complexity, Bloated Budgets and Glacial Timelines

From ARO to CRO to Sponsor, we scale the eAdjudication® software platform to the demands of your organization and your trial. We configure the software to the details of your adjudication charter, so that forms, workflows, data management and data exports all contribute to meeting the goals set forth in your trial’s charter. Study teams, reviewers and committee members work seamlessly online in real time to expedite judgements, consensus and timely completion of the endpoint adjudication process.

How the eAdjudication® Software Platform Fits into the Endpoint Adjudication Process

From collecting and assembling medical records into the electronic adjudication dossier to exporting structured adjudicated data and metadata for regulatory submission, our enterprise software service relieves your clinical team from the burdens of software and data management.


eAdjudication® Software Features

Designed to to Simplify all the Endpoint Adjudication Processes
and to Avoid Most Common Operational Pitfalls

YOUR NEED: As a Provider of Endpoint Adjudication Services to Sponsors you need a single environment to handle all of your Customers's Studies, each one with a different Adjudication Charter.

OUR ANSWER: A Distinct eAdjudication® Multi-Study Platform for each one of the Ethical's Customers. eAdjudication® provides you with a physically separated platform exclusively dedicated to you. We can configure it to exactly match your Standard Procedures (SOPs) while retaining the flexibility of using it for many different studies, each one separated, with its specific forms, workflows, users' roles, data integrations, custom reports and exports.

AS RESULT: You can match your SOPs with the Flexibility required to serve different Sponsors with different Charters. You Gain all the possible Economies of Scale of using a single Software Platform for all of Your Studies.

YOUR (CRO) NEED: To simplify the day-by-day work of your Staff (Central Endpoint Office) and minimize the risk of Delays, Omissions and Errors.

OUR ANSWER: A Single Events' Repository Real-Time View-Page for Each Study. eAdjudication® provides your Central Staff with a Single Repository per-study displaying all the Events currently in the database. It can be configured with different columns (Event Attributes) and Filters (Event Status) so that each event can be easily searched and monitored during its lifecycle. This intuitive tool can be used by your Staff and the Committee Members practically without training.

AS RESULT: Your Staff works fast and easily keeping a real-time complete oversight of Events' Workflow Advancement and Status. You Match Sponsors' Service Level Agreement for Quality and Operations Timing.

YOUR NEED: To collect Event-related Source Medical Records from Sites in a Timely and Quality Controlled manner – To track and manage Queries' Resolution

OUR ANSWER: Direct access to the eAdjudication® Platform for Site Staff for Uploading Documents and Solving Queries. eAdjudication® provides your Study Investigators with access to a dedicated System Area where they can find the check-list of the Medical records they need to upload for each event. The uploaded events are received, tracked and versioned. The Central Staff is notified about each new version and can decide to accept or refuse it. All queries for a given site are managed, tracked and solved in a single view.

AS RESULT: Your Staff manages Sites, Medical Records and Investigators' Queries in the most timely and quality controlled way. You can prevent one of the most common cause of delays in study completion.

YOUR NEED: To collect Event Data in The Most Effective and Charter-Compliant Way – To lower Time of Delivery of new Studies.

OUR ANSWER: Ethical's Staff take directly care of Online Adjudication Forms Design and Implementation. eAdjudication® provides Reviewers with specific Adjudication Forms for each Event. Forms Interface Design, Field Labels, Edit Checks and Data Variables used to Store the Adjudication Committe Assesments are customized by the Ethical's Staff to match exactly each Study Charter. The Forms' Design Process can start even before the Adjudication Charter final approval. Ethical Staff uses a Form Description Language that can be used to define, modify and test the new Forms independently from the Customer's platform delivery. Forms can be saved as Templates and repurposed for future studies.

AS RESULT: You Reduce Substantially the Time of Each New Study Start. Your Committee will deal with quality designed Adjudication Forms that can be saved and repurposed for future studies reducing implementation time and budget.

YOUR NEED: To support Different Charter Workflow Requirements for Assessment, Disagreement Detection and Resolution.

OUR ANSWER: Ethical's Staff designs and delivers New Studies already configured to match all Charters' Specifications.
eAdjudication® is the most flexible Solution in the Market. Our model of full-service delivery has been designed to comply with any non-standard procedures that each Sponsor or Adjudication Commitee decides to choose for their Charters. Different Algorithms for Event Assignment to Reviewers, Two, three or more levels to consolidate the panel's assessments, any workflow chosen for Disagreement Management detection and resolution all are efficiently handled by Ethical's engineers and delivered in the shortest time to your staff.

AS RESULT: With a single platform you can setup and manage the most heterogeneous Adjudication Studies without expensive Trainings to your Staff.

YOUR NEED: To Ensure a Timely and Compliant Execution of Your Endpoint Adjudication Studies by detecting operational Bottlenecks and correcting them as fast as possible.

OUR ANSWER: Ethical designed eAdjudication with the Study Coordinator's Dashboard for real-time control and reporting over the study day-by-day operations. At eAdjudication®, we have experience from dozens of studies and we understand the metrics that Study Staff need for monitoring and reporting. Events detected and Assessed, Reviewers' Workload, Alerts for Outliers and Delays against operational benchmarks, Number of Events in each workflow status. Each represented by a dedicated widget that can be printed or exported.

AS RESULT: Operations Oversight and Reporting to your Managers or Sponsor can't be faster and easier. All Operational Metrics in a single, customizable, view.

YOUR NEED: An efficient Quality Control Process that follows the most common Standard Practice or can be easily adapted to specific Charter's Requirements.

OUR ANSWER: Ethical designed its Adjudication Quality Control features following a robust control process by monitoring quality metrics throughout the study duration and importing “clone events” for Intra-Variability detection.
eAdjudication® makes available a specialized set of features to deal with Study Quality Control. In particular a Quality Control Dashboard that includes all the relevant metrics: Total events, number of events per-Reviewer, by Time period, by pair of Reviewers, with Disagreement Rates, etc. A process is also available as a standard feature allowing to re-submit a fraction of the already adjudicated Events (usually 5 or 10%) to the panel to verify the consistency of assessments. The process can be adapted or customized to match specific features of each study.

AS RESULT: Quality Control Oversight and Reporting to your Managers or Sponsor is available to your staff in real-time. All Quality Control Metrics are available in a single, customizable, view.

YOUR NEED: Providing Adjudication Data to Data Managers during the conduct of the Study and support Adjudicated Events' Data Submission at the End of the Study.

OUR ANSWER: Ethical provides a User's Profile and a Set of Features dedicated to your, or your Sponsor’s Data Managers. eAdjudication® allows the Data Managers to ask for a real-time Data Export directly from inside each study environment. Standard Exports include CSV, XML, Excel files about Audit rail, Events' Lifecycle History, Adjudication Outcomes, etc. Other customized data formats (e.g. SAS), Structures or Contents are available on request and once configured can be made available to each study in the Customer's Platform. A dedicated set of data and documents, suitable for submission to Authorities, is made available at the end of each study.

AS RESULT: Endpoint Adjudication Data are always available in real-time as soon as the study starts. configured to match your specifications without complex or time-consuming operations.

YOUR NEED: To following your (or your customer’s) needs in terms of Study Data Environment Architecture, Security and Compliance with the Charter or Regulation

OUR ANSWER: Ethical is available to analyze, design and implement any type of integration to allow clinical data exchange with each eAdjudication Platform. eAdjudication® is designed and managed by clinical data integration engineers with access to all the necessary technical interfaces and expertise to move data from and inside the study database. The most common features are the automated import of Events from the Study Electronic Data Capture System ( E.g. Medidata Rave EDC) and the connection of the Events Package viewer with a DICOM Imaging database. Other types of Integration with Operational Tools (e.g. BOX) or newer technologies for ensuring data compliance and privacy (e.g. Blockchain) are available with limited time and effort.

AS RESULT: You are confident that your Endpoint Adjudication Solution is able to adapt to current or future integration requests without imposing to your staff the heavy constraints of traditional out-of-the-box centralized solutions.

An Endpoint Adjudication Solution You Can Have Confidence In

Systems and Data Hosted and Managed in an ISO/IEC 27001-Certified Environment

Ethical’s software design and service provisioning are based on a hardware/software and organizational structure that ensures compliance with the ISO/IEC 27001 information security management system requirements and security controls.

Computer Software Validation Expertise

Ethical’s software, systems, and services comply with all regulations that apply to EA: GxP, GAMP 5, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11, ISO/IEC 27001. Ethical includes a validation package. If required, Ethical also provides the full GAMP 5 validation documentation package and support.

Clinical Data Management Expertise

Ethical Staff gained experience in providing software solutions to support some 300 global clinical trials with more than 10,000 investigator sites and hundreds of thousands of patients. 

Request a Demo of the eAdjudication® Software Solution

Download Ethical eAdjudication for Endpoint Adjudication Dossier

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