At PHUSE US Connect 2023, PointCross Life Sciences presented a new way to automate the mapping of raw clinical EDC and non-EDC (biomarker) data to SDTM mapping through a Universal Data Model (UDM). Reducing the time to SDTM from weeks to days with built-in traceability, we discussed how SDTM programming and mapping for statistical analysis outputs has traditionally been labor and code intensive. You can review the accompanying paper: “EDC Raw Data to SDTM Curation, Mapping and automation with the Xbiom tool”
UDM is a F.A.I.R. repository standard that is built with a metamodel to represent all collected data in a study along its timeline, for each subject or its samples. It standardizes all raw and CDISC metadata (files, variables, data, etc.). and made analysis ready and ready for transformation into any exchange format.
Non-programmers can access Xbiom – a statistical computing environment, with a simple, low-code interface for control and visualization of EDC raw data. Clinical Study Managers and Biomarker Scientists, for example, can focus on continual building of a curated single-truth view of the clinical trial as it progresses since Xbiom tool ‘remembers’ previous data corrections. Xbiom’s recommendations of each SDTM variable mapping helps when EDC raw data is refreshed.
Presentation: PHUSE US Connect Presentation
Watch Recording: Harmonizing Raw Data with CDISC Standards to Streamline SDTMs presented by Sunil Gupta
In this webinar, co-hosted by CDISC SME and author Sunil Gupta & PointCross Life Sciences talks about a new way to automate EDC and biomarker data standardization to SDTM. A brief demonstration of Xbiom platform highlighting Xbiom user interface framework and process to harmonize and curate raw data sources for a single-truth exploratory view of the data.
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.