Endpoint Adjudication Software Features
Event's package creation
Three ways for the event's creation can be combined and sequenced in the same study configuration:
- interactive upload of one of more documents;
- interactive data entry of key variables or patients narratives;
- 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;
- Quality Control real-time 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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Does this service offer guides, tutorials and or customer support?
Does this service offer multi-user capability (e.g. teams)?
eAdjudication is a cloud software services and includes all the activities need to design, manage, train and GxP software validation
What platforms does this service support?
The eAdjudication platform is a multi-study environment with user profiles on a per-study basis
Who are the main user groups of this service?
Cloud Based web application
What is this service generally used for?
Academic Research Organizations; Clinical Research Organizations; Pharma & Biotech Companies; Medical Devices Companies; Imaging Companies.
What are some applications this service is commonly used in tandem with?
To support with a complete software service the process of Central Endpoint Adjudication by a Committee of blinded Expert Clinicians.
Mainly used in Clinical Trials for drug and Medical Devices development.
Does this service offer an API?
Electronic Data Capture (EDC) - Medical Imaging Databases
APIs are available for Event Dossier building through Medical Records collection from external source systems
No FAQs associated with this application.