Current Edition


Evolution of the Trial Master File Process

There are a number of challenges facing the pharmaceutical industry, such as improving the quality of TMF documentation through a compliant centralised filing system. With the emergence of eTMFs, a new challenge has developed around the electronic management of eTMF between CROs, sponsors, and vendors. Scott Grossman at ExL Pharma explains why, in a global environment, there is a need to focus on ensuring confidence when providing TMF for regulatory inspection and legal discovery.