Florence Site Enablement Platform Security and Compliance

This document is a technical report that outlines how Florence’s Site Enablement Platform addresses security and compliance concerns in clinical trial management. It details the platform's design focused on data integrity, system validation, and access control, ensuring adherence to industry standards and regulatory requirements. The report presents a comprehensive suite of features that facilitate seamless integration and provide a secure environment for critical data. Key aspects include compliance with ALCOA++ principles, HIPAA regulations, and FDA 21 CFR Part 11 for electronic signatures. The platform employs advanced encryption, role-based access, and automated audit trails to maintain data integrity. Additionally, it discusses the importance of ongoing training, incident response management, and the establishment of a dedicated GDPR Taskforce to ensure compliance with data protection regulations. The report emphasizes the platform's capability to support research sites globally while maintaining high security standards.