PointCross Life Sciences recently collaborated with Sunil Gupta at the PHUSE Winter Single Day Event in beautiful Cary, North Carolina.
Refer to the paper below that introduces a way to automatically map EDC raw data and metadata to SDTMs and ADaMs through the Universal Data Model (UDM) on Xbiom.
Quick brief: The Universal Data Model (UDM) offers an attractive method to traditional SDTM programming and mapping. Non-programmers can access a simple, low-code interface for control and visualization of EDC raw data to SDTM mapping through a universal data model which standardizes all metadata (files, variables, data, etc.).
Xbiom from PointCross comes with built in SDTM conformance rules, and leverages EDC raw data and metadata attributes to strategically compare and map them to SDTM metadata and control terminology variables and derivations. 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. 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.
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#UniversalDataModel #UDM #SDTM #ADaM #clinicalstudies #PhUSE #clinical
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