TMF SERVICES

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.

Montrium TMF Services

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
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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
SPEAK TO AN EXPERT
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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

 

TEMPLATE DEVELOPMENT

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.