Automated SDTM generation, straight from EDC
Curation dashboards integrate ancillary studies and biomarker assays with your EDC and eCRF data in a F.A.I.R. Unified Data Model. From the UDM, SDTM datasets are generated automatically with your selected Implementation Guide and Controlled Terminology.
SAP lockouts are periodic. Translational needs are not.
Analyses on periodic EDC data lockouts are prescribed by the SAP, but translational needs are frequent, or ad hoc, to meet the analysis of bench-to-bedside data. Xbiom™ makes it easy to continually curate new patients and visit data, keeping an ever-fresh, curated view of the trial in the UDM.
Curate continually, not just at lockout
New patients and visit data are curated as they arrive, so the trial view in the UDM stays fresh between the SAP-prescribed lockouts.
EDC, eCRF and biomarkers together
Curation dashboards integrate ancillary studies and biomarker assays with EDC and eCRF data in a single F.A.I.R. Unified Data Model.
A resource for the biometrics team
An important addition for Clinical Ops, biometrics and bio-statisticians: a curated UDM and SDTM in a typical read cycle saves time and supports the SAP work.
A read cycle that ends in SDTM
A typical read cycle of the EDC and biomarkers can end in a curated UDM and SDTM within 24 hours, helping quality-check and validate the data.
One model, three jobs
The F.A.I.R. Unified Data Model serves several important functions, all from the same curated, ever-fresh data view.
Find & select cohorts
Search, find, access and select stratified cohorts and their data directly from the UDM.
Analyze & generate TFLs
Analyze cohorts or individual subjects and generate tables, figures and listings on demand.
Generate SDTM
Generate SDTM with your selected Implementation Guide and Controlled Terminology, on demand.
From EDC read to validated SDTM
A typical read cycle moves from source data to curated UDM to generated, validated SDTM.
Read EDC & biomarkers
EDC, eCRF, ancillary study and biomarker assay data are read in, including newly arrived patients and visits.
Curate in the F.A.I.R. UDM
Curation dashboards integrate and curate the data into the Unified Data Model, keeping the trial view fresh.
Select IG & CT
Choose the Implementation Guide and Controlled Terminology to generate against, on demand.
Generate & validate
SDTM datasets are generated automatically and can be quality-checked with eDataValidator, also in Xbiom™.
21 CFR Part 11, with validation built in
Xbiom™ is 21 CFR Part 11 compliant, and the supporting evidence collateral for IQ, OQ and PQ is available. Combined with eDataValidator, also available in Xbiom™, the SDTM generator becomes a quality-check and validation resource for the biometrics team.
Automated SDTM generation, answered
What does the Xbiom™ SDTM Generator do?+
How fast is a read cycle to SDTM?+
Why curate continually instead of only at SAP lockouts?+
What can the Unified Data Model be used for?+
Is Xbiom™ validated and compliant?+
Turn every EDC read into submission-ready SDTM
Curate EDC, eCRF and biomarker data in a F.A.I.R. UDM, then generate validated SDTM with your chosen IG and CT, on demand. See the Xbiom™ SDTM Generator in action.
