The Future Of The TMF Reference Model

Since its inception in 2009, the Trial Master File Reference Model (TMF RM) has become the de facto standard for Trial Master File management. The chaos of every company having its own TMF structure and naming conventions (and worse) has been replaced by a common structure where inspectors, sponsors, CROs and others can all speak the same language. The resulting gains in efficiency and compliance are incalculable.   

Yet despite (or because of) its success, the TMF RM is at a tipping point. How will the model evolve to help manage increasing trial complexity and compliance demands?