Florence’s eTMF

An eTMF, or electronic Trial Master File, is the system of record for every document, signature, and audit trail your trial produces.

Florence’s eTMF software helps sponsor teams stay inspection-ready and integrate with study sites, without slowing down your timeline.

Achieve a 98%+ eTMF pass rate with continuous, automated audit trails.

See how it works

Simplify and accelerate study start-up

Quickly configure your eTMF with intuitive workflows, flexible access controls, and powerful document tools.

  • Align templates and naming with TMF structure

  • Set permissions for internal and external teams

  • Create, edit, sign, and review documents in one platform

Enhance TMF completeness and quality

Gain complete visibility into TMF status and study progress with advanced dashboards and document views.

  • Instantly view missing or expired TMF documents

  • Sync documents directly into the eTMF via email

  • Leverage Part 11 compliant eSignatures

Track study performance in real-time

Gain comprehensive insights into study progress and identify risks with advanced reports.

  • Monitor study milestones and document health in real-time

  • Quickly pinpoint at-risk areas and mitigate issues with actionable reports

  • Enhance visibility with document metrics, action items, and study attributes

Collaborate remotely with sites

Connect directly with study sites through the eISF for efficient, remote collaboration.

  • Connect with each site’s eISF for streamlined document sharing

  • Perform remote monitoring and source data verification

  • Collect, route, and query site documents securely within the eTMF

Other eTMFs promise ease of use and seamless integration with the sites eISF, but they can’t deliver 100% adoption.

Adoption

They claim ease of use…but you need a solution that’s straightforward to implement and trains your team quickly.

Flexibility

They claim standardized workflows…but you need a system that adapts to your unique processes without forcing conformity.

Collaboration

They claim site connectivity…but you need a platform sites actively engage with and CRAs can monitor efficiently.

Discover how Florence’s eTMF boosts quality and accelerates start-up across all of your studies.

Real success, real stories

Florence is used to support over 10 million monitoring workflows per month across 65k study sites in 90+ countries.

“Florence has been a great selling point for sponsors and helps demonstrate our commitment to transparency.
In addition, we’re showing our sites we want to make their lives as easy as possible too. It is a win for everyone!”

– Cari Kniola, Director of Corporate Strategy

  • Transitioned sites out of paper

  • 6 week set-up and activation timeline

  • Increased CRA satisfaction

  • 100% remote site monitoring capabilities

  • Real-time eTMF visibility and quality reporting

“Integration with eTMF and eConsent reduces errors and streamlines document management.”

  • Expanded trial reach across diverse regions

  • Improved efficiency and compliance

  • Seamless integration into Digital Data Flow

Integrate with the tools you use every day.

Drive results that matter

Mitigate Risk

Stay inspection-ready with automated audit trails, version control, user permissions, and secure in-app redaction.

Accelerate Timelines

Cut study start-up times by up to 50% and reduce study close-out by two weeks with effortless workflow streamlining.

Increase Capacity

Save 20-30 hours weekly and boost CRA efficiency by 25x, allowing more focus on patient care and less on administrative tasks.

In clinical research, compliance is crucial. We’ve got you covered globally.

Accelerate Your Clinical Trials