Florence eBinders

Florence eBinders, developed by Florence Healthcare, is a comprehensive electronic Investigator Site File (eISF) and Participant Binder platform purpose-built for research sites. Unlike solutions primarily designed around sponsor workflows, Florence eBinders is built with a site-first philosophy, offering the flexibility to adapt to each site's unique processes and full integration with existing clinical systems. It enables research sites to digitize, automate, and manage investigator site files, participant binders, and electronic logs from study start-up through close-out, while simultaneously providing remote monitoring access for sponsors and CROs.

Florence eBinders supports over 10 million monitoring workflows per month across 30,000 sites in more than 90 countries, making it one of the most widely adopted electronic site file solutions in clinical research globally.

Regulatory Workflows

• Transition from paper-based ISFs to a site-controlled, web-based system for creating, managing, and sharing essential regulatory documents
• Role-based access controls to ensure appropriate document visibility across the study team
• Full version control and comprehensive audit trails to maintain inspection readiness
• Part 11 and Annex 11 compliant eSignatures for global regulatory compliance
• Digital logs to replace paper-based tracking processes
• Long-term archiving capabilities to support document retention requirements

System Administration and Study Setup

• Intuitive workflows for rapid study setup and activation, supporting digital multi-site study management
• Control and standardize eISF templates and naming conventions aligned with site-specific workflows and SOPs
• Customize granular access and permissions for the entire study team as well as external users
• Create placeholders, due dates, and task assignments to keep studies progressing on schedule
• Identify risk areas using advanced reporting tools and dashboards

Source Management and Participant Binders

• Sync source data with participant binders to consolidate all participant source data in a single location
• Integrate with CTMS and EMR/EHR systems to route certified copies directly to participant binders
• Built-in redaction controls ensure only authorized users can view Protected Health Information (PHI)
• Florence ePrinter enables secure, encrypted digital exchange of sensitive documents between clinical systems
• Supports 100% elimination of paper shadow-charts and physical binder rooms

Remote Monitoring and Sponsor Collaboration

• Empower monitors to review eISF content prior to on-site visits, enabling smoother collaboration and preparation
• Eliminate duplicate document uploads to sponsor portals through direct access to redacted participant binders
• Automate remote visit scheduling, monitor activity tracking, and follow-up communication
• Supports direct collaboration with sponsors and CROs throughout start-up, monitoring, and source data review phases

Measurable Outcomes and Customer Results

• 20–30+ hours saved per week per site, allowing more focus on patient care and less on administrative tasks
• Study start-up times reduced by up to 49.2%, with close-out accelerated by approximately two weeks
• 41.8% reduction in document cycle time and a 12.5% increase in study capacity
• Signature wait times reduced from over a week to under an hour
• Staff onboarding accelerated from weeks to days
• Supports large-scale deployments, including 1,200+ users and 1,000+ external monitors at a single institution
• Sites have managed 580,000+ documents and processed 6,500+ monthly document signatures within Florence

Key Compliance and Risk Mitigation Capabilities

• Automated audit trails and version control keep sites inspection-ready at all times
• Secure in-app redaction protects PHI during remote monitoring and document sharing
• Compliance with global regulatory standards including 21 CFR Part 11 and Annex 11

Florence eBinders integrates with the tools research sites use every day, including CTMS and EMR/EHR platforms such as OnCore, and is deployed as a web-based solution accessible across sites in more than 90 countries. Its combination of site-first design, deep integration capabilities, and proven compliance features makes it a trusted platform for research sites seeking to modernize their clinical trial document management operations.