Scalability and Adaptability
Adapts through feedback loops with continuously monitored metrics and accuracy to ensure optimal performance across different study types and requirements.
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Streamline TMF Compliance with the eTMF for Growing Biotech and Pharma Companies
Our AI-powered electronic trial master file empowers every stakeholder - from study managers and CRAs, to IT teams and business leadership - to be more compliant. By streamlining TMF compliance and eliminating manual document classification processes, TI eTMF removes the friction from day-to-day clinical operations. Learn how you can ensure quality, completeness, and timeliness with an electronic trial master file that identifies document types, extracts metadata, and auto-files into correct locations.
Simplify TMF Management & Achieve Inspection Readiness
Streamline compliance with automation
Automate metadata and indexing workflows with machine learning to make inspection readiness easier than ever with 98% accuracy. Extract data from documents and code the metadata automatically while reducing human error in misfilings.
Set up your eTMF in a matter of weeks
Launch faster with painless implementation of an eTMF system that takes weeks, not months and 24/7 support.
Improve TMF efficiency and collaboration
Streamline TMF document processing and quality control with automated, controlled document workflows in a single source of truth for your inspection readiness and decentralized collaboration.
Manage your eTMF anytime, anywhere
Developed by clinical professionals for clinical professionals, our mobile application allows CRAs to perform critical TMF tasks and oversight on the go.
Achieve inspection readiness
Maintain TMF completeness and health with real-time document processes and audit trails.
Reduce timelines and increase transparency
Speed timelines and maintain TMF health with proactive oversight enabled by dashboards, analytics, and mobile insights.
AI-Powered Intelligence for Smarter eTMF Management
Bias Mitigation
Representative data to reflect geography, language, study type, with a 'human in the loop' process to ensure quality and compliance across diverse clinical trial environments.
Transparency and Traceability
Automation scoring for metadata extraction with audit trail and logs to ensure traceability of all AI-powered document processing decisions and workflows.
Adjustable Confidence Thresholds
Configure when documents require human review versus automatic processing. Skip the indexing step if the document is processed successfully with a high confidence score, giving you control over automation levels.
Human Oversight
Adjust the amount of human insight that's needed based on your team's capacity and study requirements. Scale from full automation to human-assisted workflows through configurable review processes.
eTMF Features.
Reduce the risk of inspection findings with features that simplify trial master file management.
Get the support of on-demand TMF experts and document specialists. Request a Demo >
Leverage ML and AI for document processing, auto-coding, and metadata extraction. Identify and classify documents based on uploaded templates with pre-trained study rooms on document types and metadata fields. Request a Demo >
View planned and actual milestones and tasks in real-time by date, priority, and risk. Request a Demo >
Quickly and securely capture, index, and publish documents to the eTMF, directly from phone or tablet devices. Documents are automatically classified and filed into correct folder locations to improve TMF management efficiency. Request a Demo >
Review real-time TMF insights and oversight to make faster risk-based decisions. Request a Demo >
Enable real-time document processes, version control, and 21 CFR Part 11 eSignatures. Request a Demo >
Simplify onboarding and daily use by managing just one login for all applications and modules. Request a Demo >
Stay on top of the document workstreams and maintain a complete and quality TMF. Request a Demo >
Streamline communication with an Email and Correspondence Inbox. Request a Demo >
Configure your eTMF to custom structure requirements and keep it aligned with the most current standards. Request a Demo >
All features include: QC1/QC2 Step Workflow, Quality Review Audits, Document Query and Task Management, ML Auto-Coding and Extraction, Duplicate Checks and Comparisons, Document Certification and Redaction, Flexible and compliant Metadata configuration, Required Documents and Placeholders, Country, Site, Contact Requirements, Event Manager & Health Tracking, Completeness Views, Study Start Up integration, Email and Correspondence Inbox, Bulk Upload & Migration, Responsible Party, MyTI Mobile App, CRA Reconciliation, Site and Study Collaborate / Content Authoring Request a Demo >
eTMF Connections
Experience seamless data flow between eTMF and your systems for Investigator Database and eFeasibility, Content Management, CTMS, Study Start-Up, and Learning Management.
Automatically collect and store site feasibility responses and other essential documentation in the eTMF. Documents are classified and filed automatically to reduce manual processes. Request a Demo >
Seamlessly transition from Study Start Up to eTMF. Request a Demo >
Publish content directly to the eTMF to activate real-time inspection readiness. Extract data from documents and code the metadata automatically for seamless content management workflows. Request a Demo >
Site and study training documentation is automatically indexed in the eTMF to show training proof to inspectors. Request a Demo >
TI eTMF connects to our full suite of Site Solutions, including eISF and Site Portal, and our QMS. Request a Demo >
TI eTMF Seamlessly Connects to our 21 CFR Part 11 Compliant eClinical Platform
With built-in content management, site feasibility, study start-up, learning management, and CTMS solutions, you have a complete, central solution for on-site and remote clinical trial management.
Essential Features that Support eTMF Health
Quality
- Review and Indexing Workflow
- Quality Review Audits
- Document Query and Task Management
- ML Auto-Coding and Extraction
- Duplicate Checks and Comparisons
- Document Certification and Redaction
Completeness
- Flexible and compliant Metadata configuration
- Required Documents and Placeholders
- Country, Site, Contact Requirements
- Event Manager & Health Tracking
- Completeness Views
- Study Start Up
Timeliness
- Email and Correspondence Inbox
- Bulk Upload & Migration
- Responsible Party
- MyTI Mobile App
- CRA Reconciliation
- Site and Study Collaborate / Content Authoring
Managing your TMF is complicated. Simplify it with a next-generation eTMF system.
From site identification to close-out, clinical document processes and operational oversight are complex. Our electronic trial solutions simplify your clinical operations: expedite timelines, enable collaboration, improve quality, capture the full story of study, and pass inspections.
Latest from our leadership
No File Left Behind: The Great TMF Migration to Archive
Moving a TMF to archive should be predictable, complete, and auditable.
TMF Inspection Risk Score® Survey
Please complete the following to access the TMF Inspection Risk Score® Survey
eTMF Integration: The Minimum-Viable Flows Between CTMS and eISF
Picture the work week as a CRA. Your CTMS tells one story about sites and milestones, the eTMF another about documents and status while the site portal guards a third pile of truth no one has time to reconcile.
