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Ensure Quality, Completeness, and Health with Trial Master File Services
The Features for Compliant, Inspection Ready Trial Master Files
TMF Management
- Document processing in any system
- TMF study owner resources
- TMF quality review, document Quality Control, and completeness/gap analysis
- Paper scanning, naming, indexing, filing services, etc.
- TMF migrations and archiving
- Inspection readiness and audit support
- Metrics and KPI development
TMF Consulting Company
- Best practice workshops
- Inspection readiness workshops
- SOP and Process development and review
- TMF Reference Model Implementation
- TMF Plan creation
- Metrics and KPI development
- FDA, EMA, PMDA and MHRA inspection experience
- WCG Metrics Champion Consortium
- Barnett International Certified
TMF Education
- The world’s first and only accredited TMF University
- Multiple accreditations and certifications
- Corporate training programs
US-Based Biopharmaceutical Company With Over 350 Employees
This company was looking to reconcile a phase III study with over 450 global sites.
A large biopharmaceutical company in the middle of a pivotal phase III study, run by seven CROs and vendors, needed help with over 150,000 paper documents across their 450 global investigative sites. They turned to TransPerfect trial master file services for scanning, coding, and TMF inspection readiness expertise to help process their TMF documentation.
What's My TMF Inspection Risk?
85% of studies are delayed, and inspection findings are often a factor. Calculate your TMF Inspection Risk Score®—and know how to improve it — in less than 10 minutes.
Develop a Culture of Inspection Readiness with Expert TMF Guidance
Trial Interactive provides the TMF guidance and resources you need to stay compliant. Join the thousands of clinical research professionals who use our TMF services to reduce TMF management burdens, avoid inspection findings, and streamline inspection readiness.
Maintain global regulatory compliance.
Work with TMF experts who have FDA, EMA, PMDA and MHRA inspection experience on SOP and process development, TMF Reference Model implementation, TMF best practice and inspection readiness workshops.
Ensure TMF completeness and data quality.
Avoid potential issues with your studies through TMF guidance on quality reviews and TMF health checks that proactively identify and correct documentation and indexing issues.
Simplify TMF document management.
Work with experts for TMF document scanning, naming, indexing, TMF migrations, eTMF archiving and more.
Access the first and only accredited TMF University.
Certify your managers, leaders, and specialists in best practices with the only accredited TMF University in the world.