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Software Description:

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:

  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;
  • 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.

Features:

  • Data Export
  • File Sharing
  • External Integrations
  • Notifications
  • Data Visualization
  • Dashboard
  • API
  • Data Import
  • File Transfer

Summary:

  • Project Management Real Time Dashboard

  • Quality Control Real Time Dashboard

  • Medical records Management

  • Adjudication Committeee Management

  • Disagreement - Consensus Management

  • Data and Documents self-service Export

  • Hosting and Complete software Management

Pricing:

  • Credit card required: N/A
  • 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.

FAQs:

    Does this service offer guides, tutorials and or customer support?
  • eAdjudication is a cloud software services and includes all the activities need to design, manage, train and GxP software validation

  • Does this service offer multi-user capability? (e.g. teams)
  • The eAdjudication platform is a multi-study environment with user profiles on a per-study basis

  • What platforms does this service support? (e.g. native mobile apps)
  • Cloud Based web application

  • Who are the main user groups of this service?
  • Academic Research Organizations; Clinical Research Organizations; Pharma & Biotech Companies; Medical Devices Companies; Imaging Companies.

  • What is this service generally used for?
  • 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.

  • What are some applications this service is commonly used in tandem with?
  • Electronic Data Capture (EDC) - Medical Imaging Databases

  • Does this service offer an API?
  • APIs are available for Event Dossier building through Medical Records collection from external source systems

Publisher:

Founded:
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Based in:
-
Employees:
-
Likes:
Followers:
563

Other:

Who uses eAdjudication
  • Enterprises
Desktop Platforms:
  • Web App
Languages:
English
Regional Restrictions:
No restrictions.
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