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XBIOM™

The Study Data Automation Platform

Xbiom is now RAG-enabled with AI LLM technology, transforming how users access clinical trial and nonclinical study data.

Xbiom protects proprietary trial information that represents significant corporate investment and must never be exposed to external systems or cloud-hosted AI services. By deploying secure LLMs within corporate firewalls alongside the protected study data, Xbiom enables Retrieval Augmented Generation (RAG) capabilities that make stored data, information, and insights accessible through plain English queries via a Large Language Model chat interface. This approach provides instant access to data held in the deepest locations within Xbiom, making navigation intuitive for both experienced researchers and uninitiated users without specialized training.

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.