Florence eBinders 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 not only is our software 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 staying in accordance to all standing rules and regulations. Learn more about the people behind Florence here.

Our eBinders customers include leading cancer research institutions, NCI-designated cancer centers, academic research centers, hospitals and health systems, independent research centers, and all other organizations managing clinical trials.

eBinders Platform Capabilities Questions

Florence eBinders™ is essentially a digital version of the regulatory paper binder that enables customers to organize, store, e-sign, and track research documents and manage regulatory workstreams without the burden of historically slow and inifficent paper processes. This solution is known in the industry as an eISF or eRegulatory

Florence eBinders™ is a cloud-based web application that is accessible from anywhere in the world – reducing workload imbalances and improving cumbersome oversight requirements for physicians and research teams spread out across multiple locations. Access the online platform by logging in here.

All your current documentation and workflow processes can be performed on the platform. Documents can be efficiently collected, signed, and managed.

The primary processes include study startup, processing amendments, managing correspondence, study closeout, safety reporting, facilitating monitor or audit visits, completion of Delegation of Authority (DOA), staff training, tracking file expirations, storing patient records and documenting deviations and violations.

Learn about all the capabilities in the Complete Guide to eRegulatory.

Florence eBinders™ has been developed based on best practices in collaboration with leading research sites for the specific intended use of creating and maintaining documents and workflows. Because of this experience and focus, Florence eBinders™ 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 eBinders™ augments and is compatible with existing systems that manage institutional review boards (IRB), trial databases, patient registries, billing, coverage analysis, Electronic Data Capture (EDC), biospecimens and/or staff tracking. Learn about all the different eClinical solutions here.

Shared drives are not Part 11 compliant and therefore require the research site to maintain redundant paper binders. The FDA has and is continuing to issue inspection observations to research sites for using shared drives.

Learn more about Part 11 compliance and checklist to consider here. Shared drives lack key software features required by the FDA including: safeguards for deletion or misconduct, eSignature capabilities, audit trails, user access controls, encryption, reports and more.

A research site that develops these features in their shared drive must follow documented policies required to perform user validation, training, software development and server management. Florence eBinders™ offers all of the above

Yes, eBinders™ 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 eBinders multicenter capabilities here.

Compliance and Regulatory Questions

Yes, eBinders™ is fully 21 CFR Part 11 compliant and is in full compliance with all current rules and regulations. Learn more about Part 11 compliance here.

Cost and Reimbursement Questions

Florence eBinders is priced to reflect the ROI of the platform for the research center. We take your study profiles and organizational dynamics into account and we also examine how your Sponsor/CRO will reimburse you for the 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.

We commonly see sponsors reimburse Sites for the 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 eBinders can completely replace existing long-term archiving costs while providing financial return to the sponsor by enabling remote monitoring access and efficient onsite monitoring practices.

Customer Support and Implementation Questions

Clients typically identify an internal project manager to facilitate implementation, manage ongoing support, training and validation tasks. In our experience, this person can continue normal job functions without issues.

Depending on the number of studies you wish to transition to Florence eBinders™, implementation for all new studies can take a matter of weeks to three months. We typically see research sites up and running in a month. Florence has a designated Implementation team that guides new clients every step of the way with personalized materials, onboarding certification training course and field-tested processes.

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

From working with other 6,200 active research teams in Florence eBinders, our dedicated implementation team has developed a flexible process to ensure Investigator adoption of Florence eBinders.

Our team works closely with your organization to integrate software adoption and training best practices to guarantee positive results. Learn more about technology and PI adoption here.

Florence is dedicated to white-glove customer service. Dedicated resources are provided to facilitate clients’ understanding and efficient use of the product including a help desk, FAQ page, 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.

eBinders Tech Specs and Integration Questions

The research site owns all information inputted to Florence eBinders by its staff. The research site’s documents, electronic signatures, reports 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, eBinders™ 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 eRegulatory™ system should have, please visit our integrations debrief here.

Sponsor Acceptance and Collaboration Questions

In our experience, Sponsors are fully accepting of the use of eBinders. In fact, Sponsors are seeking out research sites that have fully-electronic processes due to the efficiency and cost reduction it contributes to clinical trials. For this reason, sponsor acceptance of site initiated software platforms is as simple as providing the needed SOPs for electronic processes at your site.

In contrast to sponsor-provided portals, Florence eBinders’ platform allows the research site to own and control documents and records from startup through long-term archiving, which are separate from the sponsor’s own records. Florence eBinders™ was built by clinical researchers, for clinical researchers, for the specific intended use of managing electronic documents and records in 100% compliance with all applicable rules and regulations.

There are specific FDA requirements for research sites that maintain electronic records and signatures. Therefore, using a sponsor-provided portal is not compliant and will require your site to keep redundant paper binders. The FDA has and is continuing to issue inspection observations to research sites not in Part 11 compliance. Learn more about Part 11 compliance here.

Florence eBinders serves as the research site’s record as compared to the sponsor’s. Furthermore, it is compatible with sponsor-provided portals and therefore augments their capabilities.

Typically, research sites on Florence eBinders will receive various documents from the sponsor via the portal and then drag-and-drop those files into Florence eBinders. Should the sponsor need to access their documents, the research site can provide access for the specific trial(s) and/or export appropriate audit-ready PDF documents for upload into the sponsor portal.

Yes, Florence eBinders fully supports remote monitoring. Research sites can allow access at any level, either the specific study, binder, folder, or document, to 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 eBinders you can do so here.

Not a part of the Florence Family? Schedule a demo so we can show you why 10,000+ research sites are.

We would love to welcome you to the Florence Network of sites maximizing their efficiency with Florence eBinders™. Let’s schedule a personal demo together so our team can show you why sites love us so much they’ve made us the #1 eRegulatory solution.

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