Endpoint Adjudication Software to Manage Event Database, Committee Assessment, Disagreement and Consensus Meetings in a GxP Controlled Environment

Eadjudication Dashboard


The eAdjudication software features have been exclusively designed for Endpoint Adjudication  

Thus, compared with general purpose eClinical systems, it can offer a USER FRIENDLY DESIGN, AN EASY & FAST CONFIGURATION, THE FLEXIBILITY TO BE  INTEGRATED WITH EXTERNAL DATA SOURCE SYSTEM (e.g. EDC, SAFETY DB, IMAGING, CTMS) and an EFFECTIVE PRICE STRUCTURE.

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EVENT'S PACKAGE CREATION

three ways for the event's creation can be combined and sequenced in the same study configuration:
1) interactive upload of one of more documents;
2) interactive data entry of key variables or patients narratives;
3) integration with patient's data source systems (e.g. Medidata Rave, Oracle Argus, DICOM Imaging, etc) through web services and integration API.

MANAGEMENT OF EVENTS' INFO REVIEW

  • visualization / comparison of data or documents included in the package;
  • merging of documents and key variables in a single narrative doc;
  • event documentation update and versioning;
  • event package status tracking.

 MANAGEMENT OF THE COMMITTEE MEMBERS

  • user profiles and roles management; 
  • dynamic assignment of events to Members;
  • reviewers qualification assessment and training;
  • communication and alerting to reviewers.

MANAGEMENT OF THE ASSESSMENT DELIVERY

  • enforcement of workflows customized to map the Adjudication Charter;
  • assessment acquisition through EDC like online Case Report Forms (single or multi-page);
  • "more data" requests & query to site handling;
  • Minor and Major Disagreement management;
  • Consensus meeting management;
  • adjudication process tracking with Audit Trail.

REPORTING & DATA EXPORT

  • smart real time reporting through Adjudication Coordinator Dashboard;
  • reporting to study Sponsor management;
  • multi format data export (PDF, XML, SAS, Excel, etc);
  • adjudication key data direct export/integration with external Data Management systems.

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eAdjudication ® is provided as All Inclusive Cloud Software Service

eAdjudication software is provided as a service package bundled together with all the hosting, technical management, validation, training & support: 

  • unlimited users Licenses of the software;
  • system configuration to map the Adjudication Charter and Workflows;
  • ISO 27001 cloud hosting for system and database;
  • server, database and study data complete technical management;
  • standard users support / integrated online Helpdesk;
  • standard users training / testing in a Clone "Stage" environment;
  • validation package documentation & support.

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DISCOVER How eAdjudication® can simplify your work:

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