Florence eBinders
Florence eBinders is a cloud-based platform designed for clinical trials, that is a fully validated FDA 21 CFR Part 11, HIPAA, ICH-GCP and GDPR-compliant service. It includes tools like digital signatures, redaction, eLogs and placeholder reporting.
Florence eBinders offers a range of project management tools. The electronic format allows for forwarding correspondence directly into eBinders via email, eSignatures, redacting/de-identifying and annotating source documents, and setting expiration dates on documents to improve efficiency and reduce duplication. Customisable Roles and Permissions allow for greater oversight of document management.
All international investigator initiated clinical trials sponsored by MCRI must use Florence eBinders to ensure that they are fully FDA 21 CFR Part 11 and GDPR compliant.
Key benefits of Florence eBinders
- Eliminate paper binders
- Electronic signature and log requests
- Multi-site management
- Save time
- Remote monitoring
- Easy digital archiving
Interested in using Florence eBinders for your research?
Sign up to access Florence eBinders for your clinical trial research. Sign up.
Contact us
For any questions, please email us at [email protected].
Resources
According to MCTC100 | Florence User Policy, all users must complete three steps before their first login to the MCRI Team folders:
- Training: Complete training on how to use Florence eBinders.
- Access at Florence eLearning Modules (Sign up invite code: FLORENCE) or contact [email protected].
- MCTC130 Workflow | Accessing Florence eBinders Training
- Wet Ink Signature: Create an original record of the user’s wet ink signature and provide both digital and hard copy to Florence Administrator
- Wet Ink Signature Page (MCRI / RCH staff – originals sent to MCTC, South Level 4)
- Wet Ink Signature Log (External staff – originals kept with Site Coordinator)
- Role and Permissions: Organise appropriate roles and permissions with the Organisation Administrator via email or the project’s Binder Administrator.
- MCTC178 Factsheet | eSignatures and Digital Signatures
- MCTC105 Guidance | eTMF Workflows and eSignature Reference Guide for IITs
- MCTC104 Guidance | eISF Workflows and eSignature Reference Guide for IITs
- MCTC103 Guidance | eISF Workflows and eSignature Reference Guide for Commercially Sponsored Studies