XBIOM Platform

The XBIOM™ Platform, developed by PointCross Life Sciences, is a comprehensive Study Data Automation Platform designed for biopharma R&D teams managing clinical and nonclinical study data. It provides an end-to-end solution for ingesting, curating, transforming, storing, analyzing, and submitting study data, supporting both experienced researchers and new users through an intuitive, AI-enhanced interface.

A standout capability within XBIOM™ is Xbiom Whisperer, a RAG-enabled AI LLM feature that allows users to query stored clinical trial and nonclinical study data using plain English through a Large Language Model chat interface. Xbiom Whisperer deploys secure LLMs within corporate firewalls alongside protected study data, ensuring that proprietary trial information is never exposed to external systems or cloud-hosted AI services. This Retrieval Augmented Generation (RAG) approach makes even deeply stored data and insights instantly accessible without requiring specialized training.

Core Platform Modules

• XBIOM™ VDR (Virtual Data Room) – Ingests study data, facilitates exchange of data and intermediate work-products among labs and CROs, supports curation, generates Errata Registers for EDCs and LIMS, and prepares data for loading into the future-proofed Universal Data Model repository.
• XBIOM™ MDR and Smart Transformer – A Metadata Repository combined with an Automated Smart Transformer that asserts all source and destination standards, manages terminology codelists for harmonization, and generates mapping registries.
• XBIOM™ UDM and Repository – A Universal Data Model and exchange-standard-agnostic, future-proofed repository indexed for query mask searches.
• XBIOM™ Regulatory – Automates the generation of submission-ready SDTM, ADaM, and TFLs; includes eDataValidator™ and a Statistical Computing Environment (SCE) with R and Python programming, plus an optional interface to SAS servers.
• XBIOM™ IGO (Immersive Graphics Object) – An integrated visualization application for generating tables, listings, and figures for research and publication purposes.
• XBIOM™ Nonclinical Insights – Provides analytics and visualization of all nonclinical studies sourced from LIMS, SEND, Biomarker Lab Assays, or Bio-Analytics, with tools for generating SEND datasets and eDataValidator (eDV) functionality.
• XBIOM™ Clinical Insights – Delivers analytics and visualization of searchable stratified cohorts, on-demand or SAP-driven statistical analysis, templated and custom plots and tabulations, and annotated TFL objects.

Validation and Efficiency Capabilities

• eDataValidator (eDV) – Offers limitless validation of clinical SDTM and ADaM as well as nonclinical SEND datasets, serving as a single solution for IND, NDA, and BLA preparation.
• Single Track Processing – Accelerates the timeline to Study Report and SEND completion to as little as 2–3 weeks total through streamlined single-track processing.

Supported Workflows and Data Standards

• Automated SDTM generation from EDC systems
• SEND dataset preparation and quality control for nonclinical submissions
• ADaM dataset generation for clinical analysis
• Biomarker assay data standardization and biosample tracking for specialty assays
• Digitization, analysis, and warehousing of legacy clinical trial data
• Digital Study Report (DSR) generation
• Interim monitoring of both nonclinical studies and clinical trials

XBIOM™ is available as a Software as a Service (SaaS) solution, optionally hosted on AWS or Azure, with on-premises installations also supported to accommodate organizations with strict data residency or security requirements.