oomnia eTMF

Electronic Trial Master Files for modern trials

software (2)

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

Integration with 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 CDISC TMF Reference Model.

eArchive

Exportable to a validated eArchive database.

Features

Group 318

Star icon 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.

Star icon 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.

Star icon 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.

Star icon 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.

Generate prolific insights from your clinical trials with a truly interoperable platform.

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