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Electronic Investigator Site File (eISF)

Trial Interactive's eISF solution reduces administration and improves speed and compliance for site personnel, CRAs, and study teams. Digital investigator 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.  
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Trial Interactive's eISF & remote site monitoring for clinical trials offers eClinical solutions for clinical site monitoring

eISF Highlights

eISF highlights: Secure, configurable remote site monitoring with eClinical solutions and 21 CFR Part 11 compliance

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 interoperability 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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“In today’s world every sponsor needs the capability for a complete remote approach to trial conduct, including document collection and management. Trial Interactive has helped us enable a critical piece of remote trial management: visibility into all documents needed to remotely oversee a clinical trial. We only touch documents once because documents flow seamlessly between GlobalLearn, the eISF, and the eTMF. With Trial Interactive, we help studies lower risk and achieve near real-time oversight, without site visits.”

Penelope Manasco, MD, CEO of MANA RBM

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

Case Study

MANA RBM Expands Remote Trial Management

Connected eISF, eTMF, and Training Management Solutions Help Teams Go Remote

Over nearly a decade, MANA RBM has leveraged technology solutions to develop the infrastructure for the data and document collection required for remote paperless trials. Trial Interactive was selected to enable the inclusion of eISFs for all research sites in clinical trials large and small. The interoperability between Trial Interactive’s eISF, eTMF, and LMS solutions enables full visibility into all documents needed to remotely oversee a trial, centralizing essential documents and certified copies of source documents while securing protected health information. Sites can even upload and generate certified electronic copies of documents to align with ICH recommendations and US law—all with a few clicks of the mouse.

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Learn More About MANA RBM and TI's Partnership

eTMF and TMF Services

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Content Management

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Trial Management

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Learning Management

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