Florence eTMF Frequently Asked Questions (FAQ)
About Florence Questions
Florence was founded by a group of passionate innovators with both technical and clinical expertise to ensure that our software is not only intuitive, but it is impactful and useful for challenges specific to clinical researchers.
Our software is purpose-built for the complex documentation and regulatory workflow needs of clinical research teams while following all standing rules and regulations. Learn more about the people behind Florence here.
Our eTMF customers include leading cancer research institutions, NCI-designated cancer centers, academic research centers, growing biotech and medical device companies, hospitals and health systems, independent research centers, and all other organizations managing clinical trials.
eTMF Platform Capabilities Questions
Florence eTMF is a digital version of the Trial Master File, allowing a convenient compilation of trial documents and providing confidence in compliance. Within it, you can create, edit, sign, gather and review trial master file documents. Florence’s eTMF can stand alone or be integrated into your current eTMF system, enabling seamless document exchange and allowing sponsors to manage all site workflows in a single system.
As a cloud-based web application, Florence eTMF can be accessed from anywhere in the world, ensuring better document quality and inspection readiness. Decrease time to file and increase speed to market, accelerating research and cures.
Access the online platform by logging in here.
All your current documentation and workflow processes can be performed on the platform. Efficiently manage due dates and file dates and track collection and signature of documents. Support study startup, manage correspondence, study closeout, and safety reporting, facilitate monitor or audit visits and staff training, track file expirations, and document deviations and violations.
Learn about all the capabilities in the Complete Guide to the eTMF.
Shared drives are not Part 11-compliant and therefore require the research site or sponsor to maintain redundant paper binders. The FDA has and is continuing to issue inspection observations to research sites and sponsors for using shared drives.
Learn more about Part 11 compliance and view the checklist here. Shared drives lack key software features required by the FDA including: safeguards for deletion of documents or misconduct, eSignature capabilities, audit trails, user access controls, encryption, reports and more.
A research site or sponsor that develops these features in their shared drive must follow documented policies required to perform user validation, training, software development and server management. Florence eTMF offers all of the above.
Yes; Florence eTMF 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 more about eTMF multicenter capabilities here.
Compliance and Regulatory Questions
Yes, eTMF is fully 21 CFR Part 11 compliant and is in full compliance with all current rules and regulations. Additionally, Florence eTMF is EU Annex 11 compliant. Learn more about Part 11 compliance here and Annex 11 compliance here.
Cost and Reimbursement Questions
Taking into account your organization’s dynamics and study profiles, Florence eTMF is priced to reflect the ROI of your research platform.
If you are interested in learning how much Florence may cost for your organization, please contact us here and our sales team will be happy to assist you.
Customer Support and Implementation Questions
Clients typically identify an internal product owner to facilitate implementation and manage ongoing support, training, and validation tasks. In our experience, this person might be a TMF Manager, Clinical Trial Associate, or Clinical Trial Manager depending on the organization’s structure.
Depending on the number of studies you wish to transition to Florence eTMF implementation for all new studies takes a few weeks to a few months. We typically see implementation completed between 8 and 9 weeks. Florence has a designated Implementation team that guides new clients every step of the way with personalized materials, onboarding certification training courses, and field-tested processes.
If you are interested in learning more about how our implementation process works, connect with us here.
Having worked with over 12,0000 active research teams across Florence products, our dedicated implementation team has developed a flexible process to ensure investigator and staff adoption of Florence eTMF.
Our team works closely with your organization to integrate software adoption and training best practices to guarantee positive results. Learn more about technology adoption and implementation here. here.
As a boutique service provider, Florence offers dedicated resources to facilitate clients’ understanding and efficient use of all products. These resources include a help desk, a FAQ page, a community forum, monthly office hours, video resources and training courses.
Our support team is available around the clock 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.
eTMF Tech Specs and Integration Questions
If you purchase Florence eTMF, data ownership stays with you. Safety reports, correspondence, file dates and document statuses, training materials, deviations, violations, and audit history can be exported and provided to the various stakeholders of the clinical trial. Florence customers have full control over which parties can see and access information and data at any given time.
Yes, eTMF has an open API, which means it can integrate with all other software systems that are open to integrate. We work with all clients to verify that their software processes are seamless across systems and duplicate work is avoided at all costs.
If you want to learn more about what software integrations an eTMF system should have, please visit our integrations debrief here.
Florence eTMF has been developed based on best practices and in collaboration with leading research sites and institutions for the specific intended use of managing and reviewing trial master file documents and trial workflows in one system. Empowered by this experience and focus, Florence eTMF does what a CTMS cannot do – create and maintain audit-ready, Part 11- compliant electronic records and signatures with comprehensive and easy-to-use features on any device.
Florence eTMF has open APIs and can be integrated with external systems that also have the flexibility of open APIs. Learn about all the different eClinical solutions here.
Collaboration Questions
In our experience, sponsors and CROs have greater success with their trials when they’re connected and aligned. Florence eTMF improves study workflows across sponsors and CROs, and sponsors are seeking out opportunities and tech products that improve study oversight, reduce cost, and accelerate startup timelines. Emerging and scaling organizations require adjustable eTMF workflows, and sponsors embrace software platforms like Florence eTMF to enable CROs to manage trials effectively.
Yes, Florence eTMF fully supports remote monitoring. Research sites can allow access at any level–including specific study, binder, folder, or document levels– so that monitors can review information and track study progress for any duration of time required.
If you want to learn more about the remote monitoring capabilities of Florence eTMF, you can do so here.