What is SDTM?
SDTM (Study Data Tabulation Model) is one of the requirements for data submission to the FDA (U.S) and PMDA (Japan). To facilitate data collection, management, analysis, and reporting procedures, SDTM offers a standard for organizing and presenting data. Implementing SDTM helps with data warehousing and aggregation, encourages mining and reuse, makes sharing easier, supports due diligence and other crucial data review tasks, and enhances the regulatory review and approval process. Additionally, SDTM is utilized in pharmacogenomics and genetics investigations, medical devices, and non-clinical data (SEND).
PointCross releases Xbiom™ SDTM Generator
PointCross provides dashboards for curating and integrating auxiliary studies and biomarker assays (CT). In order to automatically produce SDTM datasets with chosen Implementation Guide (IG) and Controlled Terminology from EDC and eCRF data stored in an F.A.I.R. Unified Data Model (UDM).
SAP prescribes analysis on periodic EDC data lockouts, however translational requirements are frequent or ad hoc to fulfill the analysis of bench to bedside data. To keep an ever-fresh and curated data picture of the trial in the UDM, it is simple to continuously curate new patient and visit data using Xbiom.
The UDM performs a number of key functions:
- Find, access, and choose the data for stratified cohorts.
- Identify cohorts or subjects for analysis and produce TFLs as needed.
- Generate SDTM on demand with chosen IG and CT.
Biometricians, biostatisticians, and Clinical Ops can all benefit from the Xbiom SDTM generator. Within 24 hours, a typical read cycle of the EDC and biomarkers can result in a curated UDM and SDTM. When used with the eDataValidator, which is also part of Xbiom, this can save time, become a valuable resource for the biometrics team, and aid in the quality checking and validation of the data.