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eTMF Excellence: Zero Errors. Real-Time Readiness.

Transform your Trial Master File from a compliance burden into a strategic advantage. Trial Interactive eTMF leverages AI-powered automation to reduce document processing time by 40%, achieve 98% metadata extraction accuracy and maintain real-time inspection readiness—all while your team focuses on what matters: bringing life-saving treatments to market faster.

eTMF system

What eTMF Is and How It Transforms Your Operations

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Trial Interactive eTMF is more than record storage; it's an intelligent command center for your entire clinical trial lifecycle. By combining machine learning automation with purpose-built clinical workflows, eTMF eliminates the manual burden of classifying, filing, and tracking thousands of records across multiple sites, countries, and languages. The platform automatically identifies record types, extracts critical metadata, enforces compliance rules, and maintains continuous inspection readiness without human intervention.

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Your team regains 15-20% of their capacity while reducing any processing errors. CRAs can capture and file records directly from site visits using mobile devices, quality teams receive real-time completeness alerts, and study managers access instant dashboards that show exactly where attention is needed. With seamless integration to CTMS and content management platforms, the eTMF creates a unified ecosystem where records flow automatically from creation to archive, reducing inspection findings by 75% and accelerating study timelines.

Core Capabilities That Drive Results

AI-Powered Record Intelligence

 

Machine learning automatically classifies records across 424+ TMF categories with 94% accuracy, extracts metadata with 98% precision, and routes records to correct locations. This eliminates  hours of manual processing daily.

Real-Time Inspection Readiness

 

Continuous completeness monitoring, automated quality checks, and milestone tracking ensure your TMF is always audit-ready. Visual dashboards instantly show gaps, overdue records, and compliance status.

Mobile-First Record Capture

 

CRAs capture, index, and file records directly from sites using the myTI mobile app. Reconciliation reports generate instantly, saving 2+ hours per site visit while ensuring nothing is missed.

Intelligent Workflow Automation

 

Two-step QC workflows, automated placeholders, query management with email responses, and event-driven milestone tracking eliminate manual coordination while maintaining quality control.

Adaptive Compliance Engine

 

Configurable to any TMF reference model with automatic updates for regulatory changes. Built-in 21 CFR Part 11, ICH GCP, and GDPR compliance with comprehensive audit trails for every action.

Enterprise Integration Hub

 

Pre-built connectors with Medidata, Veeva, Oracle CTMS, Advarra IRB, and other eClinical platforms create seamless data flow. Records move automatically between systems without re-entry or delays.

Essential Features

Automation & Intelligence

- Machine learning classification and metadata extraction (no training required) 
- Automated record naming and filing to correct TMF locations 
- Duplicate detection and version control 
- Smart confidence scoring routes only exceptions for review 
- Bulk upload with automatic processing of thousands of records
- Email correspondence capture and automatic filing

Oversight & Control

- Real-time TMF health dashboards with KPI metrics 
- Milestone-based completeness tracking 
- Risk-based quality review module 
- Ad hoc and standard reporting with export capabilities 
- Query management with response tracking 
- Active alerts for missing records and pending actions

Platform & Compliance

- Validated 21 CFR Part 11, Annex 11, ERES, and GxP compliant environment 
- Single sign-on with corporate directory integration 
- Role-based access control with delegation support 
- Complete audit trail for all activities 
- 24/7 global support with 99.9% uptime SLA 
- Flexible deployment (cloud, dedicated, or multi-tenant)

Proven Impact Across 3,500+ Studies

  • 40% Reduction in Record Processing Time

  • 98% Accuracy in Metadata Extraction

  • 100% Error-Free Record Filing

  • 75% Fewer Inspection Findings

  • 15+ Years Serving Top Pharma and Biotech

  • Millions of Records Processed Globally

Why Leading Sponsors Choose Trial Interactive

Your Path to TMF Excellence Starts Here

Stop accepting that TMF management must be painful. Join the sponsors and CROs who've eliminated manual processing, achieved consistent inspection readiness, and accelerated their trials with Trial Interactive eTMF.

Your Path to TMF Excellence Starts Here

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