Xbiom uses a highly automated, low-touch process to generate, validate, and verify consistency of SEND datasets against the GLP Study Report.
Reduces data programming time from 6-8 weeks to as little as 1-2 weeks.
Reconciles SEND datasets against the Study Report summary tables to ensure consistency.
Generates TS.XPT, trial design domains, and Define.XML automatically.
The FDA requires SEND datasets to be capable of generating the same results published in the Study Report. Xbiom includes tools to:
The Universal Data Model (UDM) and Data Services Layer (DSL) together form the CDH.
"As collected" data from EDC and Biomarker Assays is ingested, curated, and auto-transformed by the Smart-Transformer into the UDM repository.
Uses stored MDR mappings to auto-generate SDTM with selected IG and CT.
Biostatisticians can generate listings for cohorts and flags for ADSL, BDS, and OCCDS files.
