One platform for the full study data lifecycle
XBIOM™ automates every step of clinical and nonclinical study data management, from raw data ingestion and curation to regulatory-ready submissions and cross-study analytics. Available as SaaS or on-premises.
Introducing Xbiom Whisperer
A RAG-enabled AI LLM built into the Xbiom platform. Ask questions in plain English and get instant answers from the deepest layers of your study data, without sending a single byte outside your firewall.
Secure LLMs deploy within corporate infrastructure alongside your protected study data, making institutional knowledge accessible to experienced researchers and first-time users alike.
XBIOM™ automates the full data lifecycle
Six stages, eight modules, one continuous pipeline from raw study data to regulatory submission and cross-study insight.
XBIOM™ VDR, Study Data I/O & Curation
Securely ingest study data and exchange intermediate work-products among labs and CROs. Curate raw data, generate Errata Registers for EDCs and LIMS, and prepare everything for loading into the future-proofed UDM repository.
Learn more → MDR · MetadataXBIOM™ MDR & Smart Transformer
A Metadata Repository and automated Smart Transformer that asserts all source and destination standards, manages terminology codelists for harmonization, and generates comprehensive mapping registries for seamless data standardization.
Learn more → UDM · RepositoryXBIOM™ UDM & Repository
A Universal Data Model and exchange-standard-agnostic, future-proofed repository. Exchange-format-independent and indexed for query-mask search, so your study data remains accessible and analytically ready regardless of evolving standards.
Learn more → Regulatory · SubmissionXBIOM™ Regulatory Submission
Automated generation of submission-ready SDTM, ADaM and TFLs, with integrated eDataValidator™, SCE with R and Python programming, and an optional interface to SAS servers. IND, NDA and BLA ready.
Learn more → IGO · TFL GenerationXBIOM™ IGO
Immersive Graphics Object is an integrated visualization application for generating publication-quality Tables, Figures and Listings. Create, annotate and share TFLs directly from your study data, with templated and custom output formats.
Learn more → Nonclinical · AnalyticsXBIOM™ Nonclinical Insights
Analytics and visualization across all nonclinical studies sourced from LIMS, SEND, biomarker lab assays, or bio-analytics. Includes tools for generating SEND datasets and running eDataValidator conformance checks.
Learn more → Clinical · AnalyticsXBIOM™ Clinical Insights
Analytics and visualization for searchable stratified cohorts, on-demand or SAP-driven statistical analysis, and templated or custom plots and tabulation. Cohort findings captured as annotated, self-updating TFL objects.
Learn more → eDataValidator™eDataValidator
Limitless validation of clinical SDTM and ADaM as well as nonclinical SEND, against the current CDISC standards. A single solution covering IND, NDA and BLA preparation, with annotated conformance reports and optional direct correction.
Learn more → Single Track · AcceleratorSingle Track Processing
Compress the full timeline from study completion to Study Report and SEND submission to 2–3 weeks total. A coordinated single-track workflow that runs report generation and data standardization in parallel on the XBIOM™ platform.
Learn more →Fits your infrastructure,
not the other way around
XBIOM™ is available as a fully managed SaaS or installed on-premises inside your corporate infrastructure.
SaaS — AWS or Azure
Fully managed cloud environment. Sponsor-specific, encrypted, isolated. Up and running in days.
- ✓ Sponsor-specific encrypted environment
- ✓ Hosted on AWS or Azure, your choice
- ✓ Zero infrastructure overhead
- ✓ Rapid provisioning — days, not weeks
- ✓ Monthly subscription, all modules included
Self-Hosted — On-Premises
Full installation within your corporate firewall. Ideal for organizations with strict data residency requirements.
- ✓ Data never leaves your environment
- ✓ Deploy behind your corporate firewall
- ✓ Required for Xbiom Whisperer LLM
- ✓ Full platform feature parity
- ✓ PointCross-managed updates & support
What is the XBIOM™ platform?+
What is Xbiom Whisperer?+
Does XBIOM™ handle both clinical and nonclinical data?+
What is the Universal Data Model (UDM)?+
How is XBIOM™ deployed?+
What is Single Track Processing?+
See XBIOM™ working on your data
Request a personalized demo and we will walk you through the modules that matter most for your pipeline, from SEND generation to cross-study analytics.
