Florence Workflows > Electronic Investigator Site File

Streamline Site Regulatory Documents and Administrative Workflows on an Electronic Investigator Site File

Powered by Florence eBinders, Electronic Investigator Site File workflows simplify your administrative processes and regulatory documents across single-site or multi-site locations.

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More than 10,000 sites in 45 countries trust their
Electronic Investigator Site File workflows to Florence eBinders
.

Why Sites Trust Florence with their Electronic Investigator Site File Workflows

Experience an Easy-to-use Platform

Florence is rated the #1 clinical trial workflow platform on G2 for ease of use, ease of setup, and customer support. Even the most paper-loving PI will enjoy moving to Florence eBinders – and our industry-leading implementation and customer operations team will help you do it!

Engage in Flexible Workflows

Every site is unique and has custom workflows and standard operating procedures. Florence eBinders lets you set up your structures and workflows the way you need while maintaining regulatory compliance. You can also empower remote employees to help your team work from anywhere.

Go Digital from Start-up to Close-out

Create, edit, distribute, collect, sign and review all investigator site files electronically within a single platform. Speed study start-up by as much as 40%. One NCI Cancer Center reduced average time to sign from 2 weeks to 4 hours.

Automate Compliance

Built-in compliance features include automated audit trails, version control, extensive user permission options and in-app redaction. Plus, your team is supported by our extensive compliance program to help develop SOPs for going digital.

Enable Remote Monitoring

Give sponsor and CRO monitors secure and compliant access to your electronic investigator site file. Automate scheduling of remote visits, track monitor activity, and communicate with your monitor on follow-up items.

Gain Site-wide Visibility

Global dashboards provide a single view of all your studies and project milestones. Track expired documents, missing signatures, and outstanding tasks in one central location.

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

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Electronic Investigator Site File Workflows with Florence eBinders

Accelerate Study Start-up

Experience intuitive workflows to get your study set up and activated fast.

  • Control and standardize eISF templates and naming conventions based on your workflows and SOPs for a quick setup.

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

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

  • Integrate the eISF with your CTMS to reduce duplicate study start-up workflows.

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 ISF completeness.

  • Track study milestones through custom dashboards and reports.

  • Create, assign and complete document tasks directly in the platform.

Enable Remote Monitoring

Equip your site to work with sponsors remotely on start-up, monitoring and source data review.

  • Eliminate duplicate work uploading documents into sponsor portals or vaults by giving sponsors direct access.

  • Provide secure access to redacted participant binders for source data review.

  • Collaborate with monitors on workflows with quality control and communications modules.

Remote Monitoring with Florence eBinders for eRegulatory, eSource, and eISF

What is in an Electronic Investigator Site File?

Florence eBinders supports all Electronic Investigator Site File documents and workflows.

Florence is also the leader of the eISF Reference Committee – you can download the eISF template here.

  • Site responsibility log (SRL) or delegation of authority log

  • Form 1572

  • Financial Disclosure Forms

  • Screening and Enrollment Logs

  • Protocol Amendments

  • IRB Communications – Including Submissions and Approvals

  • Training and Qualifications Documents

  • Investigational New Drug (IND) Safety Reports

  • Lab Accreditation and Reference Ranges for Central, as well as Local, Laboratories (if used)

  • Communications

  • Site Visit Logs

  • Pharmacy File

Explore the Florence eBinders Suite

Electronic Investigator Site File | Electronic Participant Binders | Electronic Logs

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

Why being rated #1 out of 190 clinical trial platforms on G2, the peer-to-peer review site, matters for you.

  • High Adoption: We lead the industry with 92%+ site technology activation per study.

  • Faster Timelines: Intuitive workflows that eliminate duplicate work mean work gets done fast.

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

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

“The Regulatory team is very happy with the process. It gives me great pleasure to have partnered with Florence to help them be more efficient with tasks.”

Director, Research Quality and Regulatory Compliance
Multi-Site Health System

“We have staff in several different locations, so having a central access point for our information was very important and a huge draw.”

Associate Director of Research Administration
Academic Cancer Center

“We manage multi-center studies, and eBinders gives us the power to be several places at once.”

Director of Clinical Research Administration
Site Network

We are committed to making you and your sites successful.

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Florence Supports Remote Workflows on a Global Scale

Florence now supports workflows between sponsors and more than 10,000 study sites in 45 countries.

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We love working with sponsors on Florence. Collaborating in real-time on a single document management platform helps us tackle study tasks faster and keep research on track.

Dr. Christina Brennan
VP of Clinical Research

Learn more about our Florence eBinders platform for sites.

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