Centralized trial filing
Bring trial documents into a shared filing environment so teams can locate the records they need.
diCELLa eTMF · Electronic trial master file
Keep trial documents organized, accessible and traceable.
diCELLa eTMF is an electronic trial master file system for sponsors, CROs and research sites. It centralizes clinical trial documents with role-based access, document activity history, completeness visibility and expiry tracking.
What eTMF supports
Capabilities in daily study work.
Completeness visibility
Review document completeness to identify gaps and organize follow-up work.
Document activity history
Follow document activity and lifecycle changes through a durable audit history.
Expiry tracking
Track document expiry to help teams identify records that need attention.
Role-based access
Control who can view, manage and act on documents according to their responsibilities.
Sponsor and site files
Support eTMF and electronic investigator site file (eISF) structures, with the document scope agreed for the study.
People and responsibilities
Who uses eTMF?
Sponsors
Maintain oversight of trial documents, completeness and document history.
CRO and document teams
Coordinate filing, document follow-up and access across the study.
Research sites
Work with site document structures and access appropriate to their role.
From requirements to rollout
Plan your eTMF implementation.
Use these steps to agree the project scope with the diCELLa team. Timing and deliverables depend on your study and the services selected.
Define the document scope
Identify study and site files, required document groups and ownership.
Map responsibilities
Agree user roles, access rules and the document follow-up process.
Review representative records
Use the demonstration to review filing, completeness, expiry and document history against your requirements.
Plan the rollout
Agree configuration, testing, training and any existing-document transfer requirements before setting the launch schedule.
eTMF gallery
See the platform interface in context.
Browse product screens as compact previews, then open any image to inspect the interface in a focused viewer.
Login area
Main dashboard
Study dashboard
eTMF structure
eTMF file details
Define your connected study
Integrations, reports and exports.
Connections within diCELLa
diCELLa positions eTMF alongside eCRF and CTMS for connected study work. Discuss the document and operational context your teams need, then agree the module configuration and data flows for your project.
Data and document handover
Include document handover, archive access and any transfer from an existing repository in your requirements. Ask the team to demonstrate the proposed process and specify file contents, metadata, formats and responsibilities in the proposal.
A proposal based on your study
What shapes your eTMF quotation?
For an eTMF proposal, describe your studies, sites, document scope, user roles and expected duration. Include existing-document transfer, related modules, training, support and end-of-study handover requirements so the quotation covers the intended workflow.
Before you choose
eTMF questions, answered.
What is diCELLa eTMF used for?
diCELLa eTMF centralizes clinical trial documents and supports filing, completeness review, expiry tracking, role-based access and document activity history.
What is the difference between eTMF and eISF?
The trial master file covers the trial documentation maintained by the sponsor and its partners. The investigator site file covers records maintained at a research site. diCELLa supports sponsor and site document structures; agree the scope and access model for your study.
Can teams track missing or expiring documents?
Completeness visibility helps teams review gaps, while expiry tracking helps identify documents requiring attention. Review your document categories and follow-up responsibilities during the demo.
Does eTMF replace eCRF?
No. eTMF manages trial documents; eCRF captures and reviews clinical trial data. They serve different needs and can be scoped within the wider diCELLa platform.
What should we prepare for an eTMF demo?
Bring a representative document structure, study and site roles, and examples of completeness or expiry checks. Include requirements for document transfer, handover and archive access so these can be discussed explicitly.
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