XBIOM™

The Study Data Automation Platform

XBIOM™ Automates Lifecycle of Study Data  

  • XBIOM™ VDR – Ingest Study Data, Exchange data and intermediate work-products among Labs and CROs, Curate, Generate Errata Registers for EDCs and LIMS and prepare for loading into future proofed UDM repository. 
  • XBIOM™ MDR and SMART TRANSFORMATION – Meta Data Repository and Automated Smart Transformation to assert all source and destination standards, Terminology codelists for Harmonization, and generate mapping registries.
  • XBIOM™ UDM and REPOSITORY – Universal Data Model and exchange standard agnostic, future-proofed Repository, indexed for query masks search.
  • XBIOM™ REGULATORY – Automated generation of Submission-ready SDTM, ADaM and TFLs, eDataValidator™, SCE with R, Python programming & optional interface to SAS servers.
  • XBIOM™ NONCLINICAL INSIGHTS – Analytics and Visualization of all nonclinical studies sourced from LIMS, SEND, Biomarker Lab Assays, or Bio-Analytics, tools for generating SEND, eDV data validator. 
  • XBIOM™ CLINICAL INSIGHTS – Analytics and Visualization of Searchable Stratified Cohorts, On-Demand or SAP driven Statistical Analysis, Templated and Custom Plots and Tabulation, Annotated TFL objects

XBIOM™ is available under a Software as a Service (SaaS) optionally hosted on AWS or Azure. On-Premises installations are also supported.