It is challenging to design cost-effective trials that can be executed on time, collect just the data that is needed, fit the available patient populations and are attractive to patients. New data sources and methods are now available, along with more sophisticated analytics to understand and make decisions to build smarter studies. Accessing these data streams is new; applying the rigor and structure needed to use the data to drive meaningful study design decisions is even newer and more challenging. Join us to hear examples of how has been done.