Florence Products > Florence eTMF

Improve Study Workflows with the Industry-Standard eTMF for Emerging and Midsize BioPharma and CRO Companies

Get set up fast with the top-rated platform in ease-of-use, ease-of-setup, and customer support. Plus, connect directly to your sites with the only eTMF integrated with the industry-standard electronic investigator site file network.

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Florence eTMF Electronic Trial Master File

Why Sponsors and CROs Choose Florence eTMF

Go Digital from Start-up to Submission

Create, edit, sign, gather and review trial master file documents from within the platform. Sponsors can also manage all site workflows in one system when connected to the Florence electronic investigator site file.

Experience Flexible Workflows

Emerging and scaling organizations demand eTMF workflows that adjust to their processes. We don’t force you into a box. You choose how you work in our platform, and you can trust you’re always compliant with global regulations.

Minimize FTE Impact

Complex systems come with complex headcount requirements. Florence is built for ease-of-use and ease of setup, and we’re ranking #1 for them, meaning you need less staff to implement and support your electronic trial master file.

Maximize CRA Efficiency

Connecting Florence eTMF to Florence remote site access allows CRAs to monitor over 60 sites a week with our system. CRA staffing bottlenecks are reduced, travel costs are reduced, and CRAs can make a greater impact on the study sites.

Improve eTMF Quality

Over 80% of your eTMF is generated at the trial site. By integrating our platform with your existing eTMF or with the Florence eTMF, you can exchange documents seamlessly. The eTMF pass rate of one customer increased from 65% to 98.7%.

Accelerate Start-up Timelines

Automated workflows like electronic logs, placeholders, eSignatures and quality assurance workflows reduce start-up times for most of our customers by 40%.

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

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Florence rated the #1 clinical trial workflows platform
for ease-of-setup, ease-of-use and customer support.

Why Florence being rated #1 for ease-of-use matters to you.

  • High User Adoption: Because your users can get in and get set-up fast, you accelerate your time to value.

  • Faster Timelines: Intuitive workflows for your sites means they get work done faster.

  • Low FTE Burden: You don’t need large dedicate IT teams to support implementation and management.

  • Always Reliable: Our customer have had 100% uptime over the last 12 months, we’re there when you need us.

“Our eTMF QA score went from a 65% submission pass rate to 98.7% by having real-time remote access to the site eISF.”

Aperio Clinical Outcomes

92% of 140 study sites in 8 countries were activated on Florence for remote source access and monitoring in four weeks.”

VP Clin Ops, Top 3 Pharma

“Our highest performing CRAs are now “visiting” 64 sites per week with remote monitoring on Florence, up from 2 per week.”

VP Clin Ops, Top 3 Global CRO

We are committed to making you and your sites successful.

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Overview of the Florence eTMF

Accelerate Study Start-up

Intuitive workflows to get your study set-up and activated fast.

  • Control and standardize eTMF templates and naming conventions based on TMF structure and SOPs for a quick setup.

  • Customize granular access and permissions for your entire study team and external users (regulatory agencies, CROs, sponsors, sites, etc.).

  • Create placeholders, due dates and task assignments to keep studies progressing.

  • Create, distribute and complete customizable electronic logs.

Improve TMF Timeliness and Completeness

Multiple methods of creating and gathering TMF documents combined with advanced dashboards.

  • Visualize entire eTMF, including site files when integrated with SiteLink™, with a single click to quickly identify missing or expired documents.

  • Upload documents directly into the eTMF by dragging and dropping or browsing your computer files.

  • Sync documents directly into the eTMF with a simple email.

  • Leverage Part-11 compliant eSignatures to complete and finalize all document types within the system.

Track Study Performance in Real-Time

Keep track of your entire study and identify risk areas with advanced reports and dashboards.

  • Run reports around document health metrics, open action items, study attributes, and TMF completeness.

  • Track eTMF and study site milestones through custom dashboards.

  • Dig deeper with completeness and timeline metrics to identify bottlenecks.

  • Identify at-risk areas faster with real-time visibility into site documents.

Remotely Collaborate with Study Sites

Deploy and connect to the electronic Investigator Site File (eISF) at every study site.

  • Distribute binders, documents and placeholders to your sites electronically.

  • Collect, route and query documents from your sites into secure areas of the eTMF.

  • Create document queries and communicate with your sites through the monitor review module.

  • Activate remote site monitoring and remote source data verification with SiteLink™.

Florence Supports Remote Workflows on a Global Scale

Florence now supports workflows between sponsors and more than 10,000 study sites in 44 countries.