In light of regulatory requirements, CDISC SDTM is now the leading standard for representing clinical data. Still, the use of SDTM poses many challenges. Since EDC systems can’t automatically generate SDTM datasets, converting the raw clinical data is a manual, lengthy and error-prone process. Additionally, the fact SDTM is set to support a broad array of clinical data elements means it is extensible and often open for interpretation which in turn creates many SDTM inconsistencies across studies. These inconsistencies together with the lengthy timelines of converting the data, prevent sponsors from performing cross-study analysis, increase regulatory submission costs and greatly defeats the purpose of using SDTM from the first place.
In this session, we examined current industry trends and progress made in automating, accelerating and unifying the SDTM conversion process and in enabling true cross-study analysis within organizations.