Electronic Trial Master File
Maintaining an inspection-ready Trial Master File (TMF) goes beyond simply storing documents. Study teams need assurance that the TMF accurately mirrors real-time study activities without relying on constant manual reviews and reconciliation efforts.
NoveraRM’s eTMF seamlessly updates as study milestones and tasks are completed, significantly reducing the burden of filing management and document oversight as studies grow in scale.
Smarter Oversight as Your Studies Grow
Maintaining an inspection-ready Trial Master File (TMF) demands more than document storage alone. Study teams need the confidence that their TMF accurately reflects real-time study activity without the burden of ongoing manual checks and reconciliation.
NoveraRM’s eTMF updates automatically as study work progresses, streamlining filing management and reducing review efforts as studies expand in scale.
What You'll Gain with NoveraRM eTMF
Save Time with NoveraRM's Automated Workflows
As work is completed across NoveraRM’s EDC and CTMS, documents and metadata are populated automatically minimizing manual filing and reconciliation.
Data You Can Act On with NoveraRM
NoveraRM’s eTMF surfaces quality, timeliness, and completeness through embedded dashboards and reports. Teams can direct review and QC effort using live data, addressing gaps as they emerge rather than waiting on periodic checks.
Designed for Integrated Teamwork
eTMF supports high document volumes and structured collaboration across sponsors, CROs, and sites. Role-based access and a site-focused experience streamline workflows and maintain consistency as complexity increases.
Migration
Quickly Migrate TMF Data
eTMF supports live study migrations and long-term archiving, enabling active studies to transition smoothly without disruption. Role-based access and a site-focused experience streamline workflows and maintain consistency no matter how complex your studies become.
FAQ
How does NoveraRM's eTMF integrate with its EDC and CTMS?
NoveraRM’s eTMF is unified with its EDC and CTMS on the NoveraRM Platform, allowing it to instantly auto-populate content and data from these applications. For example, data from the EDC populates directly into dashboards, and monitoring visit reports generated in the CTMS are automatically filed into the TMF — ensuring the system remains complete and contemporaneous without manual uploads.
Does NoveraRM's platform support the DIA TMF Reference Model?
Yes. NoveraRM’s eTMF provides full support for the Drug Information Association’s (DIA) TMF Reference Model and includes an out-of-the-box DIA file plan configuration. This ensures that study plans can be generated quickly while maintaining industry standards for compliance.
What is the typical implementation timeline for NoveraRM's eTMF?
NoveraRM’s eTMF is designed for rapid deployment using agile planning and implementation methodologies. Typically, the installation process — from kick-off to go-live — takes as little as six weeks.
How does NoveraRM's system handle document search and retrieval?
NoveraRM’s eTMF utilizes advanced search algorithms that allow users to locate artifacts based on content, title, and metadata. Powered by auto-naming capabilities, the system ensures content is standardized making it simple to search and manage both regulated and non-regulated content within a single interface.