Xbiom™ SDTM Generator
PointCross 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 this unified model, SDTM datasets can be automatically generated with your selected Implementation Guide (IG) and Controlled Terminology (CT) on demand.
24-Hour Cycle
A typical read cycle of the EDC and biomarkers can end in a curated UDM and SDTM within 24 hours, saving time for biometrics teams.
Powered by F.A.I.R. UDM
The Unified Data Model serves as the central hub for your clinical trial data operations.
Cohort Analysis
Search, find, access, and select stratified cohorts and their data instantly.
On-Demand TFLs
Analyze cohorts or subjects and generate Tables, Figures, and Listings (TFLs) on demand.
SDTM Generation
Generate SDTM datasets with selected IG and CT with a single click.
Validation & Compliance
Xbiom™ ensures regulatory readiness not just through automation, but through built-in validation and compliance standards.
- ✓ Built-in eDataValidator for quality checks
- ✓ 21 CFR Part 11 Compliant Platform
- ✓ IQ, OQ, and PQ validation evidence available
- ✓ Traceability from source to SDTM
Quality Assurance
Automated validation with eDataValidator ensures submission-ready quality.
Continuous Curation
Continually curate new patients and visit data for an ever-fresh view.
