Labcorp: Increase Quality and Reduce SDTM Development Time with Test Study Data Simulator

Today, having SDTM ready domains even before First Patient First Visit is becoming the industry norm. However, in many environments these early programs are built on small sets of UAT or test data which often create more programming issues later. Using the Robotics and Artificial Intelligence concept, our team developed the Test Data Simulator tool to generate the test data for more than 250 subjects covering all possible Study Design Scenarios.

The test study data simulator can save significant time and cost, especially when implemented early in the study. A data simulator uses the protocol defined data points and creates data fit for use with all scenarios considered. Helps in defensive programming with all possible What-If data conditions. The input to the simulator is Medidata Rave’s Architecture Loading Specification. The system then simulates the subject details in the protocol with added configuration and validation rules applied. The output file are clinical views of the data converted into SAS data. The preliminary created SDTM data then be used to draft other upstream ADaM and TLF programming well before normally scheduled.