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:
- For Sites: Purpose-built for site workflows, Florence enables seamless document digitization, electronic consenting, participant enrollment, and system integration. Learn more about Site Enablement Solutions for sites here.
- For CROs: Florence enhances digital connectivity, automates document distribution, and optimizes CRA workflows and site analytics to improve operational margins. Learn more about Site Enablement Solutions for CROs here.
- For Sponsors: Florence provides complete oversight of site operations with automated workflows and robust collaboration tools to reduce risks and simplify vendor management. Learn more about Site Enablement Solutions for sponsors here.
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.
Yes, Florence offers an open API, allowing integration with any compatible software system. We work closely with clients to ensure seamless processes across systems and minimize duplicate work.
Additionally, Florence has developed specialized workflow integrations with various Site Enablement partners to streamline clinical trial processes for sites, sponsors, and CROs.
Want to learn more about how our integrations can work for you? Contact us here.
Florence offers robust document retrieval and search functionality, allowing users to quickly locate specific documents using keywords, metadata filters, and advanced search queries. This feature enhances productivity and streamlines document access for site personnel.
For more details regarding Florence’s global search capabilities, users can visit this article in Florence’s Help Desk.
Yes, Florence allows authorized users to set access permissions at the team, binder, folder, and document levels. Team Admins can define user actions by creating roles, adjusting permissions, and assigning roles to users.
For more details on roles and permissions, users can visit the Roles section of Florence’s Help Desk here.
No, there are no limits on the number of studies, documents, or users that can be managed in Florence.
Yes, source documentation can be securely stored within Florence. Key eSource features include:
- Fillable forms for real-time data capture
- Creation of compliant certified copies of source data
- eLogs to keep logs updated and accessible
- ePrinter integration with Electronic Health/Medical Records
- Monitor Review Module for sponsor access to eSource
Florence centralizes source data collected from paper or other software, providing clinical staff with a complete view of participant data in one place. This central hub also supports remote monitoring, allowing monitors to access authorized documents and data without needing to visit the site.
Florence’s ePrinter enables secure, encrypted digital exchange of study documents between clinical systems, replacing traditional paper printing. It allows you to “print” documents directly into designated eBinders within Florence, streamlining document delivery to the eRegulatory Binder and eliminating the need to store sensitive files on shared desktops or physical printers.
With Florence’s ePrinter, you can send files from any Windows application, including EHR platforms and web browsers, directly to Florence. For a smooth setup, we recommend consulting your IT team to review installation, security requirements, and any compatibility considerations with institutional policies or VPNs like Citrix.
Florence users can read more about Florence’s ePrinter here.
Study information can be stored for the duration of your contract and for a limited period afterward, which varies by customer. Please refer to your Florence agreement for specific details.
For additional information on long-term archiving, users can view our Long-Term Archiving FAQs in Florence’s Help Desk.
Onboarding and Implementation
No software installation is required; you only need an up-to-date browser. Florence performs best with the latest versions of these preferred browsers:
- Google Chrome
- Microsoft Edge
- Safari
Florence currently does not support Firefox or Internet Explorer. Please note that Microsoft has discontinued support for Internet Explorer.
If you encounter issues while using an unsupported browser, switch to Chrome, Safari, or Edge first. If the problem persists, contact Florence Support at support@florencehc.com for assistance.
Florence’s dedicated Implementation team supports new clients every step of the way, offering personalized materials, best-practice recommendations, certification training, and proven workflows to ensure a smooth setup and optimized operations.
Timing depends on the Site Enablement Solution and the level of service included in the selected implementation package. Our pre-configured best practice offerings can have a team live in as little as four weeks, while our full-service implementation options allow you to spend several months with our onboarding experts for a tailored experience that will set your organization up for success from the start.
To learn more about our implementation process, connect with us here.
With a proven track record supporting over 20,000 active research teams and consistently ranked #1 by sites on G2 for the past three years, Florence’s dedicated implementation team offers a flexible, results-driven adoption process. We work closely with your organization to integrate best practices in software adoption and training, ensuring seamless integration and positive outcomes for your team.
Learn more about technology adoption and implementation here.
Florence’s eBinders™
Florence’s eBinders is a digital solution that replaces traditional paper regulatory binders, allowing customers to organize, store, e-sign, and track research documents effortlessly. It streamlines regulatory workflows by digitizing, automating, and integrating investigator site files, participant binders, and logs, eliminating the delays and inefficiencies of paper-based processes. eBinders also enables remote monitoring, providing sponsors and CROs with real-time access to essential documents.
For Florence customers, Florence will set up your organization with your designated Site Admin. The Site Admin can then invite additional team members to participate in studies by adding their email addresses, assigning them roles, and setting permissions. New users receive an email to activate their accounts (if they don’t already have one) and join the team.
If you’re using Florence eBinders through a sponsor or CRO, Florence will also handle the initial setup. Once complete, the Site Admin receives an email invitation for eBinders training and to activate the eISF, from which additional staff can be added and access levels assigned.
Florence eBinders is a cloud-based web application that is accessible from anywhere in the world – access the online platform by logging in here.
Florence’s eBinders supports all your current documentation and workflow processes, enabling efficient collection, signing, and management of documents. Key processes include:
- Study startup
- Processing amendments
- Managing correspondence
- Study closeout
- Safety reporting
- Facilitating monitor or audit visits
- Completing Delegation of Authority (DOA)
- Staff training
- Tracking file expirations
- Storing patient records
- Documenting deviations and violations
Learn about all the capabilities in the Complete Guide to eRegulatory.
Florence eBinders is designed specifically to create and manage audit-ready, Part 11-compliant electronic records and signatures, focusing on document and workflow management in collaboration with leading research sites. Unlike a CTMS, Florence eBinders provides comprehensive, user-friendly features for maintaining regulatory documents on any device.
Florence eBinders is also compatible with other systems like IRB management, trial databases, patient registries, billing, coverage analysis, Electronic Data Capture (EDC), biospecimen tracking, and staff management, enhancing your existing eClinical ecosystem.
Clients typically assign an internal project manager to oversee the implementation, support, training, and validation tasks. For a fully customized implementation, this role may require a full-time commitment during the initial phase. However, clients opting for a pre-configured solution often find the transition requires a low amount of effort, allowing only a minor impact to the project manager’s regular day-to-day responsibilities. This flexibility ensures that the transition can be adapted to fit the organization’s specific needs and resources.
Implementation for eBinders depends on the level of service included in the selected implementation package. Our pre-configured best practice offering can have a team live in as little as four weeks, while our full-service implementation options allow you to spend several months with our onboarding experts for a tailored experience that will set your organization up for success from the start.
Florence’s dedicated Implementation team supports new clients every step of the way, offering personalized materials, best-practice recommendations, certification training, and proven workflows to ensure a smooth setup and optimized operations.
To learn more about our implementation process, connect with us here.
Sponsors are highly supportive of research sites using Florence’s eBinders due to the efficiency and cost savings it brings to clinical trials. Many sponsors actively seek sites with fully electronic processes. To ensure sponsor acceptance, simply provide the necessary SOPs for electronic workflows at your site.
Unlike sponsor-provided portals, Florence’s eBinders allows research sites to retain full ownership and control of their documents and records, from startup through archiving. Developed by clinical researchers for clinical researchers, Florence’s eBinders ensures 100% compliance with all regulatory requirements.
Using a sponsor-provided portal alone is not compliant with FDA requirements for electronic records, meaning your site would need to keep redundant paper binders. The FDA has issued inspection findings for sites not adhering to Part 11 compliance.
Florence’s eBinders serves as the research site’s primary record system while seamlessly complementing sponsor-provided portals. Sites can drag-and-drop files received from the sponsor’s portal into Florence’s eBinders. If sponsors need access to specific trial documents, sites can provide secure access or export audit-ready PDFs for upload into the sponsor’s portal.
Yes, Florence’s eBinders fully supports remote monitoring. Sites can grant access at any level—study, binder, folder, or document—to enable sponsors and monitors to review information and track study progress for any required timeframe.
Learn more about Florence’s eBinders remote monitoring capabilities in our Complete eReg Evaluation Checklist.
Florence’s eTMF
Florence’s eTMF is a digital platform designed to simplify and streamline the management of the Trial Master File (TMF) in clinical trials. It provides a secure, compliant solution for compiling, editing, signing, and reviewing trial documents in a single, easy-to-use system. By connecting sponsors, CROs, and study sites through a centralized interface, Florence eTMF facilitates real-time collaboration and reduces the complexities of document handling.
Florence eTMF helps research teams save time, improve site collaboration, and ensure regulatory compliance, ultimately allowing them to focus more on their studies and less on paperwork.
Florence’s eTMF supports all your current documentation and workflow processes, including:
- Managing due dates, file dates, and document signatures
- Study startup, correspondence, closeout, and safety reporting
- Monitoring or audit visits, staff training, file expiration tracking
- Documenting deviations and violations
Discover all capabilities in the Complete Guide to the eTMF.
Typically, clients appoint an internal product owner—often a TMF Manager, Clinical Trial Associate, or Clinical Trial Manager—to oversee implementation, support, training, and validation tasks. This approach ensures a smooth transition without disrupting regular duties.
Implementation for Florence’s eTMF varies based on the level of service included in the selected implementation package. Our pre-configured best practice offering can have a team live in as little as four weeks, while our full-service implementation options allow you to spend several months with our onboarding experts for a tailored experience that will set your organization up for success from the start.
Florence’s dedicated Implementation team supports new clients every step of the way, offering personalized materials, best-practice recommendations, certification training, and proven workflows to ensure a smooth setup and optimized operations.
To learn more about our implementation process, connect with us here.
Florence’s eTMF is designed specifically for managing and reviewing Trial Master File documents and workflows, offering audit-ready, Part 11-compliant electronic records and signatures across any device. Unlike a CTMS, Florence eTMF focuses solely on document management and trial workflows, providing open APIs for integration with other flexible systems.
Sponsors and CROs achieve better outcomes when aligned on workflows and systems. Florence’s eTMF enables collaboration and improves study oversight, helping sponsors reduce costs and accelerate startup timelines. Many sponsors actively seek tech solutions like Florence’s eTMF to empower CROs and ensure efficient trial management.
Yes, Florence’s eTMF fully supports remote monitoring.
Learn more about Florence’s eTMF remote monitoring capabilities in our Complete eTMF Capabilities and Evaluation Checklist.
Florence’s eConsent
Florence’s eConsent is a secure, user-friendly digital solution for informed consent, allowing participants to review and sign consent forms from any device, anywhere. It replaces traditional paper-based consent with a streamlined, fully digital process, making it easier for participants to engage and access information about their studies.
Florence eConsent currently supports English and Spanish. However, the platform is adaptable and can be expanded to support additional languages based on customer needs.
Florence’s eConsent is priced to reflect the value it brings to your organization, tailored to your study profiles and organizational needs. To learn more about pricing for eConsent, please contact us here, and our sales team will assist you.
As a cloud-based application, eConsent is accessible worldwide to both clinical users and participants, ensuring improved document quality and inspection readiness.
Yes, Florence’s eConsent can be used for all your US studies and in over 90 countries worldwide.
For guidance on global regulatory requirements for eSignatures and their use, access our guide here.
Existing eConsent customers can find detailed help articles here.
Florence provides a complimentary IRB Submission package to assist in obtaining approval during implementation.
The integration between eBinders and eConsent is seamless and requires no additional setup. You can use the same account for both systems, easily navigate between them, and save all signed consent forms directly to your eBinders folder in just a few clicks.
To make sure your integration is set up, users can follow this step-by-step guide from Florence’s Help Desk.
Yes, Florence eConsent can be used as a standalone feature.
Our eConsent customers can access help articles on the use of eConsent here.
Typically, clients appoint an internal project owner—often a Clinical Regulatory Manager, Nurse Educator, Clinical Research Nurse, Clinical Trial Associate/Manager, or Clinical Project Manager—to oversee implementation, support, training, and validation tasks. This ensures a smooth transition while allowing the project owner to manage ongoing responsibilities.
Implementation for Florence’s eConsent usually takes between 6 to 12 weeks, depending on the number of sites and project team availability. Most implementations are completed in 6 to 8 weeks.
Florence’s dedicated Implementation team supports new clients every step of the way, offering personalized materials, best-practice recommendations, certification training, and proven workflows to ensure a smooth setup and optimized operations.
To learn more about our implementation process, connect with us here.
Florence’s SiteLink®
Florence’s SiteLink is a Site Enablement Solution designed to facilitate real-time collaboration between sponsors and research sites throughout the study lifecycle. Key features include site searching, remote site activation, document workflow automation, and remote monitoring. SiteLink enables sponsors to seamlessly distribute, track, and exchange study documents with sites, anytime and anywhere.
Florence’s SiteLink is priced based on your organization’s specific study needs and expected ROI. For pricing details, contact our sales team here, and they’ll be happy to assist.
During implementation, Florence will set up your organization within SiteLink. Once the setup is complete, the first users will receive email invitations to join. Following the link in the invitation, you’ll be prompted to create a profile with basic details about yourself to begin using SiteLink.
Access the online platform by logging in here.
Florence’s SiteLink is a Site Enablement Platform that provides a direct, digital link between the eTMF and the site’s eISF, enabling fully remote, real-time collaboration. This integration enhances TMF timeliness, completeness, and quality while strengthening site relationships and accelerating study timelines.
Learn more in our Guide to Connecting the eTMF and eISF.
Yes, SiteLink’s bulk document distribution feature allows you to send one or multiple documents to multiple sites simultaneously, helping you streamline workflows and save time across your studies.
For more information, our SiteLink customers can access help articles on the use of SiteLink here.
Clients typically assign an internal project manager to oversee the implementation, support, and training tasks. For a fully customized implementation, this role may require a full-time commitment during the initial phase. However, clients opting for a pre-configured solution often find the transition requires a low amount of effort, allowing only a minor impact to the project manager’s regular day-to-day responsibilities. This flexibility ensures that the transition can be adapted to fit the organization’s specific needs and resources.
System validation tasks are often addressed by a team member typically coming from a quality and/or compliance division within the organization, and the level of effort is dependent upon the client’s organizational requirements for software validation.
Florence’s dedicated Implementation team supports new clients every step of the way, offering personalized materials, best-practice recommendations, certification training, and proven workflows to ensure a smooth setup and optimized operations.
Timing depends on the level of service included in the selected implementation package. Our pre-configured best practice offerings can have a team live in as little as six weeks, while our full-service implementation options allow you to spend several months with our onboarding experts for a tailored experience that will set your organization up for success from the start.
To learn more about our implementation process, connect with us here.
My Sponsor or CRO Uses Florence
Your sponsor or CRO has chosen Florence’s eBinders as the eISF solution to support your study. They cover the cost of eBinders to streamline clinical trial management, enhance document collaboration, and enable remote monitoring, reflecting the commitment to efficient site operations. By partnering with Florence, they provide you with complimentary access to the leading eISF platform.
Yes, Florence offers a variety of resources to help users maximize eBinders, including a help desk, FAQ page, community forum, Q&A sessions, video tutorials, and training courses tailored to user needs.
Access our site resources here.
Note: Some resources require login. If you’re already using Florence, check your welcome email for a link to your study-specific resource page, which may include additional tools.
If you’re receiving access to eBinders through your sponsor or CRO, there are no charges for this access. However, if you’d like to expand your use of Florence to access additional features or manage other studies, please contact us here to discuss options with our sales team.
During implementation, Florence sets up your organization on the platform. Once setup is complete, a designated Site Admin receives an email invitation to join eBinders training and activate the eISF. From there, additional staff can be added, and access levels assigned as needed.
For more information, users can visit our Help Desk here.
The site retains ownership of the eISF and controls access for remote monitoring. Sites can grant access at any level—study, binder, folder, or document—allowing monitors to review information and track study progress as needed.
Florence’s eNcounter
Florence eNcounter is an enrollment automation solution that streamlines and optimizes the participant journey. It equips research sites with tools to centralize participant management, automate pre-screening, and gain real-time insights into the enrollment funnel. By reducing manual tasks, accelerating timelines, and enhancing compliance, eNcounter makes the enrollment process more efficient and effective.
Florence’s eNcounter is priced based on your organization’s specific study needs and expected ROI. For pricing details, contact our sales team here, and they’ll be happy to assist.
Florence’s ParticipantLink™
ParticipantLink is a StudyReady database that helps sponsors build and maintain a pool of study candidates for future matching. It provides insights into recruitment performance, enables automatic routing of matched candidates to study sites, and ensures efficient progression of study leads through the enrollment process—all while offering full visibility into enrollment metrics.
Florence’s ParticipantLink is currently available for early access to select customers. To learn more, sign up here, and a member of our sales team will be happy to discuss further details.
Florence’s StudyOrganizer
Florence’s StudyOrganizer is a free, user-friendly tool that centralizes your study bookmarks, passwords, and contacts, giving busy research sites quick access to all essential study information.
Learn more about Florence’s StudyOrganizer here.
Get started for free in less than five minutes by signing up here.
If you already have an account, access the online platform by logging in here.