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Electronic ISF

Paperless Site File Management and Remote Site Monitoring

Centralize investigative site file management and monitoring.

Trial Interactive's eISF solution reduces administration and improves speed and compliance for site personnel, CRAs, and study teams. Digital investigative site binder processes maintain certified copies of source file documentation and essential documents required for each clinical study. A seamless, connected eTMF allows for automatic indexing of essential documents to the TMF. The ability to conduct remote site monitoring, recommended by the FDA and EMA, helps CRAs work more efficiently in today's increasingly virtual environment while reducing travel expenses.  

eISF Highlights

Reduce regulatory compliance risks by organizing documents following study-specific requirements.

  • Configurable document types, index
  • Dashboards & workflows
  • Study links to other central vendor & sponsor portals as needed
  • Separate, configurable folders for content containing PHI
  • Document upload, auto-classification, auto-naming & download
  • Location for common reference documents such as protocol, amendments, training materials & manuals
  • User-friendly dashboard
  • 24/7 help desk (email/phone support)
  • Start-up (1572, financial disclosure) document Signature workflow
  • Learning management system introperability for site personnel & patient training
  • Connected eISF & eTMF rooms
  • 21 CFR Part 11 compliant eSignature
  • Document de-identification & redaction to protect PHI
  • Multiple site access from a single room with controlled, site-specific document access
  • Study FAQs to centralize site questions 
  • Configurable, site-specific reporting
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Simplify Site Monitoring Tasks Now!

  • Centralize All Site Documentation Online

  • Expedite Completion of Regulatory Documentation

  • Secure Site Documentation and Personnel Access

  • Streamline Document Processes and CRA Review

  • Comply with Global Regulatory Requirements for Archiving

  • Improve Site and Sponsor Satisfaction

  • Reduce Travel Time and Costs for Study Personnel

  • Maintain Real-Time Inspection Readiness