Harmonizing Raw Data with CDISC Standards to Streamline SDTMs

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In this webinar, we introduce a new, automated mapping of raw clinical EDC and biomarker data to SDTM mapping through the Universal Data Model which standardizes all raw and CDISC metadata (files, variables, data, etc.).

Xbiom leverages EDC raw data and metadata attributes to compare and map to SDTM metadata and controlled terminology variables and deviations. Users then visually review and confirm Xbiom’s recommendations of each SDTM variable mapping and data. SDTM programming and mapping for statistical analysis output has traditionally been labor and code intensive.

Fast Turnaround: Rather than a 6-week turnaround cycle following a database lock, SDTM can now be generated in 24 hours after the automatic and user mapping process. Non-programmers can access a simple, low-code interface for control and visualization of EDC raw data to SDTM mapping.

Minimal Repetition: Users then visually review and confirm Xbiom’s recommendations of each SDTM variable mapping and data, while Xbiom remembers and learns the clinical study’s profile. This greatly helps when EDC raw data is refreshed.  We’d love to address all the questions and concerns that come to your mind when you think about the topic.

Download: CDISC-360 Mission: SDTM Design and Automation 

Download: End-to-End Clinical Study MetaData-Driven Process

If you have anything in particular that you’d like to be discussed, let us know at: ask@pointcross.com