oomnia eTMF - 2026 Pricing, Features, Reviews & Alternatives

oomnia eTMF is a comprehensive document management system designed specifically for clinical trials. The system provides centralized storage for all trial documentation, including study protocols, informed consent forms, ethics committee approvals, monitor reports, safety reports, and data management plans. Through standardized cataloguing and indexing that adheres to the TMF reference model, the platform ensures consistent organization and easy retrieval of documents during audits and inspections.

The eTMF system maintains continuous inspection readiness through real-time dashboards that display completeness metrics, including expected and missing documents. These dashboards offer critical insights and control over inspection readiness activities throughout all stages of the trial. Security features include role-based access control, data encryption both in transit and at rest, two-factor authentication, and regular security audits to ensure compliance with industry standards. The system adheres to Good Clinical Practice, European Medicines Agency, and International Council for Harmonisation guidelines while ensuring compliance with data privacy regulations such as GDPR, Swiss Data Privacy Law, and HIPAA.

Document management capabilities include simplified file upload, approval, and storage processes with pre-created placeholders that reduce the likelihood of errors. The system supports automated document indexing, categorization, and tagging, along with advanced search and filter functions that allow users to sort and categorize documents based on specific criteria. Version control and change tracking features maintain document integrity over time, with detailed audit trails recording all modifications to the eTMF structure and specific documents. The platform supports multiple export formats including CSV, XLSX, and XML, facilitating efficient data handling and report generation.