The FDA mandate for standardized submissions in both CDISC SDTM and SEND was put in place in December 2016. Now, more than ever, there is a real requirement to optimize the dataset creation process.
CDISC expert, Ed Chappell reviews the traditional, laborious method to creating clinical datasets and explores an alternative optimized approach to help you reach submission faster and easier.
He also demonstrates how to implement a hybrid approach, combining new, streamlined methods with your existing QA and SAS programming processes.
What you’ll learn:
Discover the time, cost and process efficiencies to be made.