eTMF

Florence eTMF is an electronic Trial Master File solution designed for clinical research operations teams, sponsors, and CROs seeking to simplify and accelerate clinical trial document management. Built by Florence Healthcare, the platform delivers secure, compliant workflows that connect sponsors with study sites, enabling seamless collaboration and real-time visibility across all studies and geographies.

Unlike traditional eTMF systems that struggle with adoption and rigid workflows, Florence eTMF is engineered for rapid implementation, flexible configuration, and genuine site engagement. It supports over 7.2 million monitoring workflows per month across 20,000 sites in more than 70 countries, making it one of the most widely used platforms in clinical research.

Study Start-Up and Configuration

• Quickly configure the eTMF with intuitive workflows and flexible access controls
• Align document templates and naming conventions with your TMF structure
• Set granular permissions for both internal and external teams
• Create, edit, sign, and review documents within a single unified platform

TMF Completeness and Quality

• Gain complete visibility into TMF status and overall study progress through advanced dashboards and document views
• Instantly identify missing or expired TMF documents to maintain completeness
• Sync documents directly into the eTMF via email for streamlined ingestion
• Leverage 21 CFR Part 11 compliant eSignatures throughout the document lifecycle
• Achieve a 98%+ eTMF pass rate with automated audit trails, version control, user permissions, and secure in-app redaction

Real-Time Study Performance Tracking

• Monitor study milestones and document health in real-time with comprehensive reporting tools
• Quickly pinpoint at-risk areas and take action with actionable, targeted reports
• Enhance visibility using document metrics, action items, and study attributes

Remote Site Collaboration

• Seamlessly connect with each study site's electronic Investigator Site File (eISF) for streamlined document sharing
• Perform remote monitoring and source data verification without on-site visits
• Collect, route, and query site documents securely within the eTMF environment
• Enable 100% remote site monitoring capabilities across all connected sites

Measurable Outcomes and Efficiency Gains

• Cut study start-up times by up to 40% through effortless workflow streamlining
• Reduce study close-out duration by approximately two weeks
• Save 20–30 hours per week in administrative effort across the team
• Boost CRA efficiency by up to 25x, freeing time for patient-focused activities
• Transition sites away from paper-based processes with a six-week set-up and activation timeline
• Increase CRA satisfaction and demonstrate transparency to sponsors and sites alike

Florence eTMF integrates with everyday clinical trial tools and supports global compliance requirements, making it suitable for sponsors and CROs operating across diverse regions. The platform's integration with eConsent and Digital Data Flow further reduces errors and streamlines end-to-end document management across the full trial lifecycle.