The core activity of Ethical GmbH is the development and provision of software solutions for clinical research, particularly for the management of clinical trials, endpoint adjudication, data safety monitoring and protocol deviations. The company offers flexible software with tailored support for compliance and effective management of clinical trials.
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Industry:Software Development
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Flexible software with individual support for managing independent Clinical Adjudication Committees, including event management, submission, queries and audit trail.
eDSMB® for Data and Safety Monitoring Boards
Flexible software with individual support for independent Data and Safety Monitoring Boards and Data Monitoring Committees in the clinical trials environment.
eReconciliation® for SAE Reconciliation
Software with automation features and task management for reconciling safety data throughout the entire study duration, with a complete audit trail.
eDeviation® for Protocol Deviations
Flexible software with individual support for managing independent or internal protocol deviation committees.
CRO-Safe Partnership Program
Partnership program for CROs with configuration, integrations, imports, exports, training and ongoing support for clinical committee processes.
Validation and Compliance Documentation
GAMP-5 validation package with a Validation Master Plan, User Requirements Specifications, design and functional specifications, traceability matrix, as well as IQ, OQ and PQ documents.
GDPR Compliance Support
Measures and processes for EU GDPR compliance including information audits, data protection policies, security measures, training and complaint handling.
ISO/IEC 27001-compliant systems and data processing
Software, systems and services with ISO/IEC 27001-oriented security controls, risk analyses, business continuity, backup, restore and internal audits.
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