Modernize TMF Culture To Better Support Modern Clinical Trials

By India Gardner, inSeption Group

Typically, the document-management team overseeing the TMF embraces the work’s investigative elements. Most of their time is spent in the role of problem-solvers. But beyond that core team, enthusiasm for maintaining a clear and compliant TMF is much less consistent across many organizations and across the industry.

Clear benefits emerge when TMF is made a more engaging and less overwhelming task for all who must collaborate to complete it. This can be accomplished through a combination of intuitive hiring, improved communication between stakeholder groups, and more meaningful, relevant TMF education. When these elements come together, the TMF becomes an integral part of the company’s work culture.

Build a team focused on the TMF, involving at least one or two people from each department. They act as the hub where departmental personnel can share updates, concerns, and suggestions around the TMF. This ensures more voices are heard, creates a two-way flow of TMF information, and usually bolsters compliance.