Florence eTMF is an electronic trial master file platform designed to manage essential clinical trial documentation in a structured and compliant manner. It supports the organization, review, and oversight of documents required to demonstrate that a clinical trial is conducted according to regulatory and protocol requirements. The platform provides a standardized TMF structure aligned with regulatory expectations while allowing organizations to track document completeness and status across studies. It supports collaboration between sponsors, CROs, and sites while maintaining controlled access and clear accountability. Florence eTMF emphasizes transparency, inspection readiness, and document quality. It reduces reliance on manual tracking and fragmented storage by centralizing trial documentation in a single, auditable system.

Key Features

Structured TMF Architecture

Organizes essential trial documents.

• Standardized TMF zones and artifacts
• Consistent document classification

Document Completeness Tracking

Provides oversight into TMF status.

• Visibility into missing or overdue documents
• Status indicators for each artifact

Role‑Based Access Control

Manages permissions securely.

• Controlled access for sponsors, CROs, and sites
• Clear separation of responsibilities

Audit Trails and Version Control

Supports regulatory inspections.

• Tracks document changes and approvals
• Maintains full history of actions

Collaboration Across Stakeholders

Supports shared trial oversight.

• Enables document exchange between parties
• Reduces duplicate document requests

Integration with Site Systems

Aligns TMF and site documentation.

• Supports connection with site document workflows
• Improves consistency between TMF and ISF

Benefits

Improved Inspection Readiness

Supports regulatory compliance.

• Clear TMF structure and traceability
• Easier demonstration of document completeness

Better Trial Oversight

Enhances visibility for stakeholders.

• Real‑time insight into TMF health
• Early identification of gaps

Reduced Administrative Effort

Simplifies document management.

• Less manual tracking of TMF status
• Centralized document storage and review

Stronger Collaboration

Improves coordination between parties.

• Shared understanding of document requirements
• Fewer reconciliation issues between sponsor and site files

Lower Risk of Missing or Incomplete Documentation

Improves document quality.

• Standardized processes
• Clear ownership and accountability