Trust the Process - TMF Oversight
Gillian Gittens, Director of eClinical Strategy and Solutions and Avani Amin, Associate Director of Client Solutions, discuss various aspects of TMF oversight.
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Managing your TMF is complicated. Simplify it with next-generation eTMF.
Streamline TMF Compliance with the eTMF for Growing Biotech & Pharma Companies
Our AI-powered eTMF empowers every stakeholder - from study managers and CRAs, to IT teams and business leadership - to be more compliant. By streamlining TMF compliance, 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.
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.
Set up your eTMF in a matter of weeks
Launch faster with painless implementation that takes weeks, not months and 24/7 support.
Improve TMF efficiency and collaboration
Streamline TMF document processing and quality control 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.
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.
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. 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. 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. 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. 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 >
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
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.
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2024: The Future of TMF Management
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