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 TRANSFORMER– Meta Data Repository and Automated Smart Transformer 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™ IGO -XBIOM IGO (Immersive Graphics Object) is an integrated visualization application for generating tables, listings and figures for research and publication.
- 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.
- eDataValidator – eDV offers limitless validation of Clinical SDTM and ADaM as well as Nonclinical SEND, making this a single solution for IND, NDA and BLA preparation.
XBIOM™ is available under a Software as a Service (SaaS) optionally hosted on AWS or Azure. On-Premises installations are also supported.