End to End SDTM Automation: A Metadata Centric Approach

A metadata driven approach and the seamless integration of processes and people are key to creating clinical databases that are compliant and consistent with CDISC SDTM standards. The implementation of a metadata repository (MDR) is the first step toward a metadata driven approach; we at SGS went a few steps further and built in-house tools that are linked to the MDR to achieve end to end automation of the SDTM workflow.