Florence eTMF

Florence eTMF is clinical trial document management and workflow platform, where users can create, edit, sign, gather and review trial master file documents. Sponsors can also manage all site workflows in the system when connected to the Florence electronic investigator site file.

• Control and standardize eTMF templates and naming conventions based on TMF structure and SOPs for a quick setup.
• Customize granular access and permissions for the study team and external users (regulatory agencies, CROs, sponsors, sites, etc.).
• Create placeholders, due dates and task assignments to keep studies progressing.
• Create, distribute and complete customizable electronic logs.

• Visualize entire eTMF, including site files when integrated with SiteLink™, with a single click to quickly identify missing or expired documents.
• Upload documents directly into the eTMF by dragging and dropping or browsing computer files.
• Sync documents directly into the eTMF with a simple email.
• Leverage Part-11 compliant eSignatures to complete and finalize all document types within the system.

Within the platform, the user can keep track of the entire study and identify risk areas with advanced reports and dashboards.

• Run reports around document health metrics, open action items, study attributes, and TMF completeness.
• Track eTMF and study site milestones through custom dashboards.
• Dig deeper with completeness and timeline metrics to identify bottlenecks.
• Identify at-risk areas faster with real-time visibility into site documents.

• Distribute binders, documents and placeholders to your sites electronically.
• Collect, route and query documents from your sites into secure areas of the eTMF.
• Create document queries and communicate with sites through the monitor review module.
• Activate remote site monitoring and remote source data verification with SiteLink™.