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eAdjudication software

eAdjudication® software for online user-friendly clinical adjudication

The eAdjudication® software platform supports all types of clinical adjudication acting as a central hub and repository, collecting medical records directly from trial sites and/or integrating into several clinical platforms, including EDC, safety databases, DICOM/PACS Clinical Imaging Databases and more.

eAdjudication®: your solid foundation for
a successful and reliable adjudication process

The intuitive and user-friendly eAdjudication® software connects the key adjudication stakeholders and helps manage smoothly and efficiently all types of adjudication operations, supporting data manageability, quality and security, enhancing communication, streamlining workflow, and simplifying process governance.

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Data Manageability 
Easily collect, organize and share data:

  • Seamless integration with EDC systems, safety databases, DICOM/PACS clinical imaging
  • Streamlined case preparation and processing
  • Online editors for WORD, PDF, DICOM, and EXCEL files
  • AI-powered redaction tool for PDFs and DICOM images
  • Site management module for uploading source documents and tracking communication

Data quality and security
Ensure GCP compliance

  • Availability of quality control metrics
  • Robust quality control process to ensure adjudication consistency
  • Inter/Intra-variability control measures
  • Effective management of disagreements
  • Dedicated role-based views and data segregation for enhanced security
  • Adjudication forms with built-in edit checks

Workflow and communication
Ensure a seamless adjudication process

  • Flexible system configurations for forms, workflows, data exports, and integrations.
  • Configurable adjudication workflow to adjust to sponsor, CRO, or ARO needs 
  • Adjudication form designer enabling the creation of comprehensive questionnaires
  • Centralized management of queries
  • Communication module facilitating collaboration between clinical teams and committees 
  • E-mail notifications and reminders for timely updates

Process governance
Standardardize your process

  • Real-time monitoring of process timelines and key performance indicators (KPIs)
  • Timely and compliant execution of adjudication assessments through trend detection
  • Self-service data export with real-time access
  • Archive folder for Trial Master File (TMF) support
  • Generation of FDA-compliant PDF packages containing event history
  • GCP-compliant audit trail for transparency and compliance
  • Self-training module for each profile to simplify users’ daily work and to minimize the risk of delays, omissions, and errors.

Compliant, cost-effective and user-friendly
clinical adjudication committee management

Our team of highly competent experts with hands-on experience of eAdjudication® is looking forward to help you set up your adjudication process with our flexible, GCP-compliant and cost-effective software solution. Our simple, rapid, and effective deployment process coupled with the software ease-of-use will allow you to start your clinical adjudication in record time.

eAdjudication for Endpoint Adjudication: Efficient Flexible Platform

Flexibility

Committee configuration, workflows, assessment forms, integrations, disagreement resolution can all be customized to perfectly match your study requirements.

eAdjudication for Endpoint Adjudication: Designed for Ease of Use

GCP Compliance

US 21 CFR Part 11; EU GMP Vol. 4 Annex 11; EU GDPR; ISO-IEC 27001 Systems, Services and Data Processing; GAMP 5 validation documentation package and support.

eAdjudication for Endpoint Adjudication: Scalable and Cost-efficient Solution

Cost-efficiency

A scalable multi-study platform is delivered for each customer, physically separated from other customers’, leveraging economies of scale.

eAdjudication for Endpoint Adjudication: Effective Digital Hub

Rapid deployment

The proven simple, rapid and effective deployment process managed by our responsive team minimizes the time needed for your software to be released.

eAdjudication for Endpoint Adjudication: Endpoint Adjudication Expertise

Ease of use

The tailored design, intuitive navigation and user-friendly interfaces reduce users training time; operations can start immediately after the software delivery.

Request a Demo of the eAdjudication® Software Solution

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



Download Ethical eAdjudication for Endpoint Adjudication Dossier

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