Montrium Introduces Game-Changing Trial Master File Services to Enable Life Science Organizations Scale

Montrium's eTMF Services have been carefully designed to provide value, increase inspection preparedness, and expand TMF processes.

Fremont, CA: Biopharma, a longtime backslider in technology, has started a long overdue, pandemic-driven digitalization sprint. Numerous businesses have rushed to virtualize their workforces, move teamwork to the cloud, and use technology to keep their operations and employees secure only in the previous two years.

Montrium, a pioneer in cloud-based software solutions for life sciences, launched its expert-led Trial Master File Services and its new TMF maturity educational program. These cutting-edge services get intended to assist clinical operations and TMF teams at every level of the clinical development process.

End-to-end TMF management and professional consulting services are now available to life science enterprises from a team of industry experts. The complete service options are supported by years of extensive knowledge in TMF processes and cutting-edge technology, leveling the playing field for expanding enterprises by allowing them to attain the greatest degree of TMF excellence.

"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 implement a scalable TMF program. These new TMF services offerings are in direct response to this".

Montrium's eTMF Services have been carefully designed to provide value, increase inspection preparedness, and expand TMF processes.

Montrium is offering a groundbreaking TMF training and education program dubbed TMF Maturity, in addition to a fresh core set of trial master file management as well as consulting services. This unique program is intended to provide end-to-end trial master file training for the complete clinical team and skill-building and deliverable-driven seminars. Montrium will conduct TMF Maturity Day on October 25th, 2022, to promote the launch. Attendees will access four expert-led workshops covering some of the core components of Montrium's TMF maturity framework during the one-day free educational summit.

"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."