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service packages

Full-service packages for any stage of your study

We offer comprehensive packages to support your study from end to end. Get the services you need, when you need them.

TMF Maturity training

Take your TMF maturity to the next level.

Montrium’s TMF maturity training packages provide clinical operations teams with a convenient and complete training offering to improve the knowledge of trial master file management within an organization. Carefully crafted courses, workshops, templates, and exercises help augment TMF education, while giving participants the practical tools to make positive improvements in their TMF management process.

  • Expert training
  • Comprehensive workshops
  • Powerful templates & tools

TMF management services

Put TMF management on auto-pilot

Our team of experts is available to support your trial master file management operations, freeing up your calendar to focus on what matters most: your clinical trials. Trust the leading provider of TMF management services for scaling life science organizations.

  • TMF oversight services
  • Automated indexing
  • Quality control
  • Query management
  • TMF reconciliation
  • Bespoke process optimizations

Inspection readiness services

Improve inspection readiness across the board.

The regulatory inspection landscape has fundamentally changed, and it’s not slowing down. The elusive state of inspection readiness is no longer a pipe dream. Leverage our team to assist your group in putting in place an inspection readiness framework to accelerate go-to-market.

  • Inspection readiness frameworks
  • Storyboarding implementation
  • Inspection training
  • Mock inspections
  • Checklists & guides

M&A support

Mitigate risks in mergers and acquisitions.

When your company goes through a merger or acquisition, it can be
a messy time for those working within the TMF—but it doesn’t have to be.
In the event that you've acquired a TMF, we can offer specialized packages designed to guarantee that the new TMF is inspection-ready and free of gaps.

  • Impact analysis
  • Process optimization
  • TMF mapping and harmonization
  • Master index development