eAdjudication

eAdjudication® is a cloud-based software platform developed by Ethical GmbH for managing independent clinical committee processes in clinical trials. It is designed for sponsors, CROs, and AROs who need to manage Clinical Adjudication Committees, Data and Safety Monitoring Boards (DSMBs), Protocol Deviation Committees, and related processes. The platform is GxP compliant and built to meet regulatory requirements across global markets.

Ethical GmbH has been delivering clinical data management solutions for over 30 years and launched one of the first cloud-based endpoint adjudication platforms over 18 years ago. The software is configured by Ethical's IT teams to match each study's specific charter, covering the full lifecycle from User Requirements Specifications through to study archival and GxP validation.

Core Software Modules

• eAdjudication® — supports independent Clinical Adjudication Committees, managing the full adjudication process including training, event management, submission, and queries.
• eDSMB® — supports independent Data and Safety Monitoring Boards and Data Monitoring Committees (DMCs) for sponsors, AROs, and CROs.
• eDeviation® — supports both independent and internal Protocol Deviation Committees.
• eReconciliation® — a dedicated module for safety data reconciliation, equipped with automation features, smart tools, and task management capabilities to support data management, clinical, and safety teams throughout the study duration while maintaining a full audit trail.

Key Platform Capabilities

• Manages the complete clinical committee workflow including clinical adjudication, protocol deviations, data and safety monitoring boards, data monitoring committees, and steering committees.
• Configurable to match any study design or data management architecture.
• Supports SAE reconciliation with automation features and hands-on task management throughout the study duration.
• Maintains full audit trails as required during regulatory inspections.
• Incorporates artificial intelligence to support clinical committee management processes.
• Delivers customised reports and supports personalised service in close partnership with sponsors, CROs, and AROs.
• Scales to accommodate small and medium-sized organisations as well as multinational sponsor companies, handling both small and large studies with unlimited users.

Five Operational Principles

• Expertise — over 30 years of experience in clinical data management solutions.
• Innovation — ongoing adoption of new technologies to save time and improve data quality.
• Flexibility — software can be adapted to any study design or data management architecture, with customers choosing their required level of support at each study phase.
• Scalability — supports organisations of varying sizes and study volumes, including unlimited users.
• Customer Service — close partnership model with sponsors, CROs, and AROs, including speedy delivery of results and customised reporting.

Compliance and Security Standards

• Certified under ISO/IEC 27001 for Information Security Management Systems (ISMS), audited yearly by an authorised certification authority.
• Compliant with Good Clinical Practice (GCP) guidelines.
• Meets US FDA 21 CFR Part 11 requirements for electronic records and signatures.
• Compliant with EU GMP Volume 4 Annex 11.
• Adheres to EU General Data Protection Regulation (GDPR).
• Provides full GAMP 5 validation documentation package and associated support.

eAdjudication® is delivered as a cloud-based platform with full validation documentation support and ongoing configuration assistance from Ethical GmbH's IT teams. The platform is suitable for use across the full duration of a clinical study and is designed to reduce administrative burden while maintaining the quality and compliance standards required for regulatory inspection.