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Electronic Endpoint Adjudication Software

The Managed Service for Clinical Professionals Who Are Tired of Pointless Complexity, Bloated Budgets and Glacial Timelines

eAdjudication® is the Software Platform part of the innovative Software Managed Service for Endpoint Adjudication. Configured to your adjudication study, forms, workflows, data management and exports all contribute to a GxP quality and effectively managed study. Study Teams, Committee members and Investigators' Sites work seamlessly online in real time to expedite judgements, consensus and timely completion of the endpoint adjudication process.

How eAdjudication® Fits into the Ethical's Managed Software Service.

Our Solution supports all the operations for Endpoint Adjudication Data Management. From software design and validation to collecting source medical records and exporting data for Regulatory Submission to FDA or EMA, it relieves your clinical team from the burdens and hidden costs of an Adjudication Study.

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eAdjudication® Electronic Endpoint Adjudication Software

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

WHAT YOU NEED

Endpoint Adjudication Software Needs

Save money and time optmizing the setup of multiple Endpoint Adjudication studies with different Adjudication Charters Specifications.

ETHICAL'S SOLUTION:


A distinct eAdjudication® Multi-Study Platform for each Ethical's Customers.

A Single Endpoint Adjudication Multi-Study Platform

eAdjudication® provides you with a software platform dedicated to you, physically separated frrm 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.

AS RESULT

Electronic Adjudication Result

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

KNOW MORE

WHAT YOU NEED

Endpoint Adjudication Software Needs

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

ETHICAL'S SOLUTION


A single Repository for All the Events in the Database

Endpoint Adjudication: with a single Event Repository

A Real Time View displaying all the Events in the database with their current status. It can be configured with custom Event Attributes and Filters so that each event can be easily searched and monitored during its lifecycle. It can be used by your Staff and the Committee Members practically without training.

AS RESULT

Electronic Adjudication Result

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

KNOW MORE

WHAT YOU 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.

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 about new versions. All queries for a given site are managed, tracked and solved in a single place.

AS RESULT

Electronic Adjudication 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.

KNOW MORE

WHAT YOU NEED

Endpoint Adjudication Software Needs

To collect Reviewers' Assessment in the Most Effective and Charter-Compliant Way – Reduce Training and Committee Members Errors.

ETHICAL'S SOLUTION


You get the Adjudication Forms already configured for your Study Charter

Endpoint Adjudication: Event Assessment Forms

Adjudication Forms Design, Field Labels, Edit Checks and Data Variables used to store the Adjudication Committe Assesments are designed by the experienced Ethical's Staff to match exactly each Study Charter.  

AS 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

WHAT YOU NEED

Endpoint Adjudication Software Needs

To support specific Processes & Workflows for Events' Management, Assessment, Disagreement Detection and Resolution.

ETHICAL'S SOLUTION


New Studies are delivered already configured for any SOPs and Charters' Specifications

Endpoint Adjudication: Disagreement Management

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'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.

AS 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

WHAT YOU NEED

Endpoint Adjudication Software Needs

To Ensure a Timely and Compliant Execution of Your Endpoint 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 Coordinator Dashboard

We have experience from dozens of studies and we understand the metrics that Study Staff needs 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 in a single, customizable, view.

KNOW MORE

WHAT YOU NEED

Endpoint Adjudication Software Needs

Ensure an efficient Quality Control that follows the most common Standard Practice or can be easily adapted to specific Charter's Requirements

ETHICAL'S SOLUTION


eAdjudication® includes a specialized set of features for Study Data Quality Control

Endpoint Adjudication Quality Control

Quality metrics are automatically collected throughout the study duration. The Quality Control Dashboard 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 available to import “clone events” (usually 5 or 10% of total events) to be re-submitted to the panel for Intra-Variability control.

AS RESULT

Electronic Adjudication Result

You can ensure real time Quality Control oversight to your Managers and Study Sponsor without expensive data processing outside the platform.

KNOW MORE

WHAT YOU NEED

Endpoint Adjudication Software Needs

To provide Sponsors Data Managers with needed data exports during the Study and to support Events' Data Submission at the End of the Study.

ETHICAL'S SOLUTION


A set of real time data exports available 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 about 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

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.

KNOW MORE

Request a Demo of the eAdjudication® Software Solution

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



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