Endpoint Adjudication Software to Manage Event Database, Committee Assessment, Disagreement and Consensus Meetings in a GxP Controlled Environment
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.
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.
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.
DISCOVER How eAdjudication® can simplify your work:
e Adjudication ® software printscreens