Since its inception in 2009, the TMF Reference Model has become the de facto standard for Trial Master File management. The gains in efficiency and compliance are incalculable – with the chaos of every company having its own TMF structure and naming conventions (and worse) replaced by a common structure where inspectors, sponsors, CROs and others can all talk the same language.
Yet in spite of (or because of) its success, the TMF Reference Model is at a tipping point. How will the model evolve to help manage increasing trial complexity and compliance demands?
In this Ask An Expert session attendees had a unique opportunity to pose their own questions to the co-founders of the TMF Reference Model in a live Q&A session. Karen Roy and Lisa Mulcahy, respectively Chair and Member of the Model’s Steering Committee, shared updates and a roadmap for the Model’s future.