Frequently Asked Questions

Review commonly asked questions about Florence’s Site Enablement Platform.

Pricing and Support

At Florence, we understand that every organization is unique, with distinct business objectives and study structures. That’s why we tailor our pricing to align with the specific needs of your research platform, ensuring that you see a meaningful return on investment. 

If you’re curious about how Florence can fit into your budget and deliver value to your organization, please reach out to us for more information on pricing. Our sales team is ready to help you find the perfect solution!

Yes, there are fees associated with support and onboarding for the contract owner. The cost and level of support provided vary depending on the specific needs of each customer.

If you are interested in learning more about how our implementation process works, connect with us here.

Florence’s dedicated customer service, FlorenceCare™, prioritizes the needs of our customers. Florence offers dedicated resources to facilitate clients’ understanding and efficient use of all products. These resources include a help desk, an FAQs, a community forum, Q&A sessions, video resources and training courses based on user pathway needs.

Our Support Team is available from Monday to Friday, 3:00AM-11:59PM ET, via email and through the Florence “Need Help” chat feature within Florence to quickly help with software questions as needed. If you are interested in learning more about how our ongoing support process works, talk with a Florence team member here.

We commonly see sponsors reimburse Sites for the cost of eBinders on a per-trial basis. This is typically achieved through a separate line item on the site budget or as part of existing startup and archiving fees.

Florence’s eBinders can provide financial return to the sponsor by enabling remote monitoring access and efficient onsite monitoring practices.

Learn more about preparing annual operating budgets and capital expenditures in our Guide to Preparing an Annual Clinical Trial Site Budget.

Yes; Florence’s Site Enablement Platform is equipped to support all documentation needs during a multicenter clinical trial, including distribution, tracking, monitoring, eSignatures, notifications, complex workflows, and all other document management needs.

Learn about how Florence powers a nationwide Cancer Clinical Trials Consortium to standardize research operations and enable remote collaboration for their 68 research sites and 120 PIs across the US in this case study.

Yes, Florence provides comprehensive resources to demonstrate its value in clinical trials, including improving workflows, enhancing productivity, reducing compliance risks, and simplifying site management. Here’s what Florence offers for different stakeholders:

Additional Resources:

  • For Sites: Discover the ROI of eRegulatory in clinical trials by accessing our guide here.
  • For Sponsors and CROs: Explore the ROI of Site Enablement Solutions using our free Cost Savings Analysis Tool.

Security, Privacy, and Compliance

Florence has implemented rigorous privacy and security measures to ensure adherence to the highest standards of compliance. We support clinical trial operations in over 90 countries, facilitating compliant workflows for eISF, eTMF, eConsent, electronic signatures, remote monitoring, source data verification, and more. 

Florence employs advanced security measures such as encryption, access controls through roles and permissions, and regular security audits to ensure data integrity and prevent unauthorized access to sensitive trial information. Florence is compliant with many different regulations globally, and has had a third party audit completed to confirm compliance with the following key regulations:

  • FDA 21 CFR Part 11
  • ICH GCP E6(R2)
  • EU Annex 11
  • MHRA Data Integrity Guidance

Florence also maintains a Shared Responsibility Model to ensure the technical and procedural requirements of applicable global regulations are understood. 

For additional information, access comprehensive guides, checklists, and country-specific resources on Florence’s global compliance commitment here.

Unlike shared drives, Florence’s Site Enablement Platform is fully Part 11-compliant, eliminating the need for redundant paper binders. The FDA has issued inspection observations to research sites and sponsors for using shared drives due to non-compliance.

Shared drives lack essential FDA-required features, such as document safeguards, eSignature capabilities, audit trails, user access controls, encryption, and reporting tools. Implementing these in a shared drive would require extensive policies for user validation, training, software development, and server management.

Florence’s Site Enablement Platform provides all these capabilities in one compliant solution. Learn more about Part 11 compliance and view the checklist here.

As a Florence customer, you retain full ownership and control of your data and metadata, except as outlined in our terms and conditions or as required by law.

Customers have complete authority over who can view and access their data, with audit history available for transparency.

For more details on how Florence ensures data privacy, please see our Privacy Policy.

Yes, Florence includes automatic backup functionality to ensure that trial documents and data are securely backed up at regular intervals. This feature helps in mitigating the risk of data loss and ensures continuity of trial operations.

Features and Functionality

The maximum document upload size is 20GB. Single documents over 75 MB will not preview in Florence. If you need the ability to preview the file in Florence, limit the size of a single file to less than 75 MB.

Florence supports a variety of file formats including but not limited to PDF, Word documents (DOCX), Excel spreadsheets (XLSX), images (JPEG, PNG), and text files (TXT), ensuring flexibility in document management.

For a complete list of supported file types, users can visit this article in Florence’s Help Desk.

Documents uploaded to Florence do not auto-populate to other files. However, you can duplicate documents and move them to other locations as needed. 

We recommend using Florence’s Shortcuts feature that lets you link documents across multiple locations, so updating one linked document automatically updates all instances.

For a step-by-step guide on how to create Shortcuts, users can visit Florence’s Help Desk article here.

Yes, with the right permissions, you can create new structures at the binder or folder level using structure templates. Existing structures can also be modified as needed.

For more details regarding folder structure, users can visit the Folder Structure section of Florence’s Help Desk here.

Yes, Florence allows you to request signatures for study documents directly within the platform. You can specify the signature type, reason, user, and add comments as needed. Florence’s electronic signature capabilities comply with FDA 21 CFR Part 11, ensuring all signatures are securely recorded with timestamps for a complete audit trail.

For a step-by-step guide on how to request a signature, users can visit Florence’s Help Desk article here.

Yes. Using eSignatures is not required. Instead, users may upload a copy of an ink-signed document and complete a copy certification in Florence.

Yes, Florence provides version control functionality, allowing users to upload new versions of documents while maintaining access to previous versions. This feature ensures traceability and helps in maintaining document integrity throughout the trial.

For a step-by-step guide on how to upload and access document versions, users can visit Florence’s Help Desk article here.

Yes, Florence allows users to annotate, highlight, and make comments on documents directly within the platform. This feature facilitates collaboration and enables efficient review and feedback processes.

For a step-by-step guide on how to edit a document, users can visit the Annotations sections of Florence’s Help Desk here.