Biotechnology and pharmaceutical sponsors have been operating in an outsourcing model for many years now, primarily to control the costs of drug development and respond to the globalization of clinical trials and a need for more diverse patient populations.  

Outsourcing in clinical trials allows specialized third-party groups to provide crucial clinical trial services while the sponsor monitors progress and outcomes from a distance. This operating model works well for sponsor teams that have less internal resources to manage the study and the Trial Master File (TMF) itself, but it can introduce some disadvantages in the long term.  

In the following article, we’ll be exploring how outsourcing clinical trial activity can affect the TMF management processes, and why it may be better to make use of alternatives.