Florence Healthcare

Audit Trails

Automatically log user actions on documents, providing transparency and maintaining compliance with regulatory standards.

Version Control

Track document revisions and ensure that the most up-to-date versions are always available, maintaining a clear audit trail.

Role Based Access

Customize access permissions for team members and external users, ensuring that the right people can view or edit the appropriate documents.

Regulatory Workflows

Transition from paper-based investigator site files (ISFs) to a digital, site-controlled, web-based system for easy creation, management, and sharing of regulatory documents.

Part 11 & Annex 11 eSignatures

Ensure that all digital signatures are legally compliant and secure, meeting FDA and international requirements for electronic signatures.

Digital Logs

Maintain secure, accurate logs of all actions related to regulatory documents, ensuring full compliance.

Long-term Archiving

Safely store regulatory documents for long-term access, meeting retention policies and ensuring regulatory compliance.

Integration with CTMS and EMR/EHR

Seamlessly integrate with Clinical Trial Management Systems (CTMS) and Electronic Medical Records (EMR/EHR) to streamline data exchange and participant management.

Source Management

Sync source data with participant binders, allowing for easy collection and review of all data in one location.

ePrinter

Securely exchange documents between clinical systems, enabling encrypted digital sharing of sensitive information.

Remote Monitoring

Enable sponsors and CROs to remotely access and review eISF content, allowing for better preparation and fewer on-site visits.

Study Start-up Acceleration

Automate study setup with customized templates, task assignments, and due dates to help teams stay on track and ensure faster start-up times.

Document Redaction

Built-in tools to ensure sensitive information (like PHI) is properly redacted before sharing.