XBIOM Clinical Data Automation Platform

The XBIOM Clinical Data Automation Platform (CDAP), developed by PointCross Life Sciences, is a comprehensive end-to-end solution designed to streamline all aspects of clinical and nonclinical data management for the global BioPharma industry. Built for sponsors, CROs, and research organizations, XBIOM addresses the full data lifecycle — from ingestion and curation through standardization, warehousing, regulatory submission, and advanced analytics — while maintaining compliance with CDISC, FDA, and other regulatory standards.

XBIOM is now RAG-enabled with AI LLM technology, transforming how users access clinical trial and nonclinical study data. By deploying secure large language models within corporate firewalls alongside protected study data, XBIOM enables Retrieval Augmented Generation (RAG) capabilities that make stored data, information, and insights accessible through plain English queries via a chat interface. This approach protects proprietary trial information from exposure to external or cloud-hosted AI services, while making navigation intuitive for both experienced researchers and uninitiated users without specialized training.

Core Platform Modules

• XBIOM VDR, Study Data I/O, and Curation: Ingests, exchanges, and curates study data from any source, including EDCs, biomarker labs, and CROs, preparing data for the Universal Data Model (UDM) repository.
• XBIOM MDR and Smart Transformation: A Metadata Repository with automated smart transformation capabilities supporting all source and destination standards, including terminology harmonization across clinical and nonclinical data.
• XBIOM UDM Repository: A Universal Data Model providing a future-proofed, secure, and scalable repository indexed for query masks and instant search.
• XBIOM Regulatory Submission: Automates the generation of submission-ready SDTM, ADaM, and TFLs, and includes eDataValidator, a Statistical Computing Environment (SCE) with R and Python programming, and an interface to SAS.
• XBIOM Nonclinical Insights: Delivers analytics and visualization across all nonclinical studies sourced from LIMS, SEND datasets, biomarker lab assays, or bio-analytics.
• XBIOM Clinical Insights: Provides analytics and visualization on searchable stratified cohorts, on-demand or SAP-driven statistical analysis, templated and custom plots and tabulations, and annotated TFL objects.
• XBIOM IGO (Immersive Graphics Object): An integrated visualization application for generating tables, listings, and figures for research and publication purposes.
• 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.

Key Platform Capabilities

• Data Management and Curation: Efficiently handles and organizes clinical and nonclinical data from diverse sources.
• Future-Proofed Warehousing: Provides secure and scalable storage designed to accommodate evolving data standards and growing study volumes.
• Standardization and Harmonization: Ensures compliance with regulatory submission standards including SEND, SDTM, and ADaM.
• Advanced Analytics and Visualization: Transforms raw study data into actionable insights through flexible reporting and visualization tools.
• Significant reduction in programming effort: The CDAP platform is designed to substantially reduce programming efforts for CROs and sponsors, optimizing current processes and enhancing overall productivity.

Single Track Processing

• An AI-augmented approach that simultaneously produces compliant Study Reports and submission-ready SEND datasets from a single governed data source.
• Delivers both outputs within 2–3 weeks after data lock, with reported cost savings of 30–50%.
• Eliminates the traditional bottleneck of sequential study report and SEND dataset generation in nonclinical safety studies.

Solutions and Services Offered

• SEND dataset preparation, QC (SEND-ASSURE), and quote generation for nonclinical studies.
• Digital Study Report (DSR) generation.
• Interim monitoring of both nonclinical studies and clinical trials.
• Automated SDTM generation directly from EDC systems.
• Biosample tracking for specialty assays.
• Clinical and nonclinical data repository management.
• Data standardization services covering SEND, SDTM, ADaM, and biomarker assays.
• Data Concierge (Data as a Service) for nonclinical, clinical, and translational data needs.
• Digitization, analysis, and warehousing of legacy clinical trial data.

PointCross Life Sciences serves 5 of the top 15 global pharmaceutical companies and brings over 10 years of experience in life sciences data management, with a global team operating across the US, India, and Europe. The platform is designed with a long-term vision of standardizing and contextually integrating all data collected across discovery, nonclinical, and clinical trials — including genomic and immune response data — to support precision medicine development and translational research.