Platform
eTMF
An electronic Trial Master File that maintains itself. Documents flow in automatically, filed correctly, audit-ready from day one.
What it is
FICS eTMF is a fully integrated electronic Trial Master File that eliminates manual document filing and classification. As trial activities occur across CTMS, EDC, and safety workflows, the relevant documents are automatically generated, classified, and filed into the correct TMF structure, maintaining inspection readiness at all times.
Who it's for
Regulatory affairs teams, quality assurance, TMF managers, and clinical operations teams who need a perpetually inspection-ready Trial Master File without the manual overhead.
Capabilities
Why FICS eTMF is different
Automated filing
Documents generated from trial workflows are filed in seconds, not days.
Always inspection-ready
Completeness dashboards show real-time TMF health.
Unified with ISF
Investigator site files stay synchronized with the sponsor TMF automatically.
No reconciliation
Documents originate from FICS workflows, so there is no gap between source and TMF.
AI-powered classification
AI-powered document classification and quality checks built in.
Sponsor document exchange
Streamlined collaboration between sponsors and sites, built in.
An electronic Trial Master File that maintains itself.
Documents flow in automatically, filed correctly, audit-ready from day one.
Stay inspection-ready, automatically.
See how FICS eTMF files documents from your trial workflows and keeps your Trial Master File audit-ready from day one.