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Montrium Launches Game-Changing Trial Master File Services to Empower Scaling Life Science Organizations

Montrium, a leader in cloud-based software solutions for the life sciences, announces the launch of both its expert-led Trial Master File Services and its new TMF maturity educational training. These innovative offerings are designed to support clinical operations and TMF teams at every stage of the clinical development journey.

Life science organizations can now take advantage of end-to-end TMF management and expert consulting services run by a team of industry veterans. The comprehensive service offerings are backed by years of deep experience in TMF processes and cutting-edge technology, levelling the playing field for scaling organizations by giving them an opportunity to achieve the highest standard of TMF excellence.

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“We are seeing a major shift in trial master file operations as sponsors look to take more control of TMF management, oversight, and inspection readiness,” said Paul Fenton, President, and CEO at Montrium. “With regulatory scrutiny of TMFs increasing and the industry’s major adoption of eTMF systems, sponsors need deeper support to put in place a scalable TMF program. These new TMF services offerings are in direct response to this”.

Montrium’s eTMF Services have been thoughtfully crafted to create value, drive quality, improve inspection readiness, and scale TMF operations across the board. Some of the areas Montrium now supports include:

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  • TMF process implementation and startup
  • Expert-crafted process optimization and customization
  • Ongoing TMF oversight support
  • TMF inspection readiness and mock inspections
  • Ongoing eTMF system administration
  • TMF migration and reconciliation
  • TMF maturity training and workshops
  • AI-powered automated indexing, quality control, and query management (coming soon)

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In addition to a new core set of trial master file management and consulting services, Montrium is also launching a trailblazing TMF training and education program called TMF Maturity. This new program is designed to provide an end-to-end trial master file training offering paired with skill-building and deliverable-driven workshops for the entire clinical team.

“The gateway to better TMF compliance starts with education,” said Donatella Ballerini, Head of eTMF Services at Montrium. “Our TMF Maturity Training program delivers team-focused training, practical workshops, and comprehensive templates to increase your TMF maturity in a never-before-seen combination.”

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