Oomnia eTMF
Electronic Trial Master Files for modern trials
Digitalize your document flow
Oomnia Electronic Trial Master File (eTMF) is a Trial Master File in digital format, incorporating the same integration capabilities as other Oomnia modules. It is a way of digitally capturing, managing, sharing, and storing the essential documents and content from a clinical trial, with automated options to simplify TMF population while remaining compliant with regulatory guidelines and requirements.
Benefits
Ease of Use
Get integrated all-in-one solution
Cost Reduction
Reduce costs without sacrificing functionality
Freedom
No vendor lock - transfer your data at any time
Solutions
Full integration
iIntegration sith EDC, CTMS, RTSM, Laboratory results, and more enables streamlined workflows between modules.
Oversight
Better process overview and quality metrics.
Customized mapping
Defined per organization’s standards, while following the Drug Information Association’s (DIA) TMF Reference Model.
eArchive
Exportable to a validated eArchive database.
Features
360° view of all study-relevant documentation
All documents are collected in a cataloged system. This feature lets you see the entire document array and quickly locate and view the desired document and its versions.
Streamlined communication among all stakeholders
All study participants have simultaneous access to the database of documents, taking into account their roles. Any change is logged and available for follow-up. Alerts on changes made are automatically sent to predefined study participants.
Simplified file and data upload, annotation, and hierarchical storage
Any document type in electronic format can be uploaded to the system. The document can be annotated in the way accepted in the study and placed in the file section prepared for it.
Real-time inspection readiness
At any stage of a clinical trial stage, real-time dashboards with metrics for completeness, including expected and missing documents, provide critical insights and control over inspection readiness activities.
