Scale your TMF practice in a matter of weeks
Montrium provides a full-service trial master file management offering that enables your team to focus on critical study tasks, leaving TMF to the experts.
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TMF support for every step of your lifecycle
We're more than just a TMF consultancy, we're a team of experts that understand clinical trials like you do. As your trusted partner, we help your team generate value and insights from the TMF to drive quality and improve inspection readiness no matter the phase or milestone.
TMF Management Services
Comprehensive TMF management support backed by years of experience and innovative technology.
Includes support with:
- TMF oversight
- TMF process optimization
- eTMF system administration
- Automated document indexing & processing
- Quality control
- Query management
- TMF reconciliation
- TMF migration
Expert TMF consultancy
Strategic consulting services tailored to your TMF environment.
Includes support with:
- TMF Health Checks
- Master TMF index development
- Ongoing TMF oversight
- TMF inspection readiness
- Mock inspections & storyboarding
- TMF plan development
- CRO oversight planning
- Strategic process development
- TMF metrics strategy
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Turn your team into a lean, mean, TMF machine
We offer training and education for the bootstrappers, the go-getters, and the TMF leaders of tomorrow. Expert-led and backed by years of experience, our programs will help you gain the internal skills you need to successfully scale.
Essentials
Training + Workshops
Our TMF Maturity Essentials package will enable you to hit the ground running with your eTMF system. We'll get everyone on your team up to speed about TMF processes, functions and regulatory requirements. Participants will also get a chance to gain hands-on experience in our interactive workshops.
Topics covered
- TMF Principles & GCP
- TMF Index & Reference Model
- The eTMF Plan
- TMF Document Quality Checks
Intermediate
Training + Workshops
The TMF Maturity Intermediate Package is a follow on from the essentials package and broadens your skillset with a focus on TMF quality, data integrity, compliance, and oversight. After learning the theory, your team will dive deeper in customized workshops targeted to truly decode the regulations impacting your TMFs, the importance of TMF quality control and understand your organization’s TMF Maturity.
Topics covered
- Oversight through TMF
- TMF Data Integrity
- Current TMF Regulations
- TMF Quality Control
- eTMF Process & Models
Advanced
Training + Workshops
Our TMF Maturity Advanced Package helps you and your team reach the highest TMF maturity state so that you’re always ready for an inspection. This package is designed to help you truly grasp the most advanced concepts and optimize your current processes to efficiently manage winning TMFs. While the training sessions will cover the theory, the workshops are where you’ll get your hands dirty and transition your team to the next level of TMF maturity.
Topics covered
- TMF Risk-based Approach
- TMF Inspection Readiness
- TMF Metrics & KPIs
- TMF Storyboards
- TMF Quality by Design
Powerful templates and tools to accelerate TMF maturity
We understand the importance of balancing strategic TMF support with practical, deliverable driven activities. As part of our TMF services offerings, our team can support your team in putting in place critical documentation you'll need to scale and improve TMF processes and management.
eTMF Plan template
Standard eTMF Business Rules
eTMF Management SOP
WI for Trial Setup & System Admin
WI for Document Lifecycle Management
Master TMF Index template
TMF Document QC Checklist
Sample TMF QC Report
Inspection Readiness Framework
Case Studies & TMF Reference Articles
Inspection Readiness Checklist
Customized QbD Process
TMF Storyboard Template
TMF Metrics Report Template
TMF Mock Inspection Framework
Other custom template development
Turn your TMF into a lean, mean, TMF machine
Book a consultation call today with one of our TMF experts
TMF support for every step of your lifecycle. We’re more than just a TMF consultancy, we’re a team of experts that understand clinical trials like you do. As your trusted partner, we help your team generate value and insights from the TMF to drive quality and improve inspection readiness no matter the phase or milestone.