Ethical

Ethical GmbH develops cloud-based software solutions for clinical committee management in clinical trials. The company serves sponsors, contract research organisations (CROs), and academic research organisations (AROs), providing tools that cover endpoint adjudication, data and safety monitoring boards, protocol deviation committees, and safety data reconciliation. Ethical's IT teams configure each software deployment to match the specific study charter, supporting customers from User Requirements Specifications through to study archival and GxP validation.

Founded on more than 30 years of experience in clinical data management, Ethical created one of the first cloud-based platforms for endpoint adjudication over 18 years ago. The company describes five core principles guiding its work: expertise, innovation, flexibility, scalability, and customer service. Its software is designed to accommodate any study design or data management architecture, and the platform can scale to serve small and medium-sized organisations as well as multinational sponsors, handling both small and large studies with unlimited users.

Core Software Products

• eAdjudication® — A configurable software solution with customised support for managing independent Clinical Adjudication Committees. It handles the full adjudication process including training, event management, submission, and queries.
• eDSMB® — Software designed to support sponsors, AROs, and CROs in managing independent Data and Safety Monitoring Boards (DSMBs) and Data Monitoring Committees (DMCs).
• eDeviation® — A solution for managing both independent and internal Protocol Deviation Committees, guiding users through complex deviation review processes.
• eReconciliation® — A dedicated software for safety data reconciliation, equipped with automation features, smart tools, and task management capabilities. It allows data management, clinical, and safety teams to perform reconciliation throughout the study duration while maintaining a full audit trail for regulatory inspections.

Compliance and Security Standards

• Ethical's software and business processes are built to meet internationally recognised regulatory requirements, including Good Clinical Practice (GCP), US FDA 21 CFR Part 11, EU GMP Vol. 4 Annex 11, GAMP 5, and the EU General Data Protection Regulation (GDPR).
• The company holds ISO/IEC 27001 certification for Information Security Management Systems (ISMS). Ethical's parent company, GM Servizi, is audited annually by an authorised ISO 27001 Certification Authority.
• Ethical provides a full GAMP 5 validation documentation package and associated support services to customers.
• The software infrastructure is designed to ensure compliance with GDPR requirements for EU data protection.

Deployment and Support Model

• Software is delivered as a cloud-based platform, with IT teams configuring each instance to match the specific study charter and requirements.
• Support spans the full study lifecycle, from initial User Requirements Specifications through GxP validation and final study archival.
• Ethical offers a CRO-Safe Partnership Program, reflecting a close working model with CROs, sponsors, and AROs.
• The company provides customised reports and personalised service, with an emphasis on speedy delivery of results.

Artificial Intelligence Integration

• Ethical's software solutions incorporate artificial intelligence features to support clinical committee management processes.
• The company states a commitment to leveraging new technologies where they can contribute to saving time and improving data quality.

Ethical GmbH positions itself as a long-standing specialist in clinical committee software, combining regulatory compliance, configurable technology, and hands-on operational support to assist clinical teams in managing complex committee processes with reduced administrative burden.