Transforming Vendor Biomarker Data into CDISC Compliant SDTM Datasets

About this session

Part of Session 5, Track A: Foundational Standards - Advanced Standards (Chair: Srinivasa Rao Mandava, Merck).

Biomarker data from external vendors are often delivered in proprietary or non-standard formats, creating challenges for analysis, traceability, and regulatory submission. This presentation describes a pragmatic approach for transforming vendor biomarker data into CDISC compliant SDTM datasets using internal mapping tables developed. Early standards engagement ensures that only biomarker data relevant to study objectives and Clinical Study Report requirements are mapped, minimizing unnecessary transformations and downstream rework. The approach includes identifying raw vendor data elements, applying CDISC controlled terminology, aligning data to appropriate SDTM structures, and capturing mapping metadata to support transparency and reproducibility. This methodology enables consistent and analysis ready biomarker datasets across studies, improves data quality, supports traceable derivations, and enhances regulatory readiness. Attendees will gain practical insights into integrating diverse vendor biomarker data into submission ready CDISC standards across programs while supporting reuse and long-term governance models for biomarkers.

Speakers

• DG

  Devi Gohimukkula

  BeOne Medicines

  Speaker

• SK

  Saravanan Kandasamy

  BeOne Medicines

  Speaker