Automated SDTM Generation from EDC

Curation Dashboards and integration of EDC and Biomarker Data for SDTM

PointCross has released Xbiom™ SDTM Generator. This module provides dashboards for curating and integrating ancillary studies and biomarker assays to EDC and eCRF data held in a F.A.I.R. Unified Data Model (UDM) from which SDTM datasets can be automatically generated with selected Implementation Guide (IG) and Controlled Terminology (CT).

Analysis on periodic EDC data lockouts are prescribed by the SAP, however, translational needs are frequent, or ad hoc, to meet the analysis of the bench to bedside data. Xbiom™ makes it easy to continually curate new patients and visit data to maintain an ever fresh and curated data view of the trial in the UDM. The UDM serves many important functions:

  • Search, find, access, and select stratified cohorts and their data
  • Analyze cohorts or subjects and generate TFL’s on demand
  • Generate SDTM with selected IG and CT on demand

Xbiom™ SDTM generator can be an important addition to Clinical Ops, biometrics, and bio-statisticians. A typical read cycle of the EDC and biomarkers can end in a curated UDM and SDTM within 24 hours. This can save time, become an important resource for the biometrics team, and help in quality checking and validation of the data when combined with the eDataValidator, also available in Xbiom.

Xbiom is 21 CFR Part 11 compliant and the supporting evidence collateral for IQ, OQ, and PQ are available.