PointCross

PointCross Life Sciences is a technology company specializing in Clinical Data Automation for the global BioPharma industry. Through its flagship XBIOM™ platform, PointCross delivers end-to-end solutions covering data ingestion, curation, standardization, warehousing, regulatory submission, and advanced analytics for both clinical trials and nonclinical studies. The company serves CROs, sponsors, and life sciences organizations seeking to streamline data management workflows while maintaining compliance with CDISC, FDA, and PDMA standards.

The XBIOM™ platform 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 systems or cloud-hosted AI services, while making navigation intuitive for both experienced researchers and new users without specialized training.

XBIOM™ Platform Modules

• XBIOM™ VDR, Study Data I/O, and Curation: Ingests, exchanges, and curates any study data sources including EDCs and biomarkers from labs and CROs, feeding into the Universal Data Model (UDM) repository.
• XBIOM™ MDR and Smart Transformer: Provides a Metadata Repository and automated smart transformation for all source and destination standards, including terminology harmonization.
• XBIOM™ UDM Repository: A Universal Data Model and future-proofed repository, indexed for query masks and instant search.
• XBIOM™ Regulatory Submission: Automates generation of submission-ready SDTM, ADaM, and TFLs, with eDataValidator™, a Statistical Computing Environment (SCE) supporting R and Python programming, and an interface to SAS.
• XBIOM™ Nonclinical Insights: Provides analytics and visualization of all nonclinical studies sourced from LIMS, SEND, biomarker lab assays, or bio-analytics.
• XBIOM™ Clinical Insights: Delivers 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.
• 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: Helps nonclinical CROs accelerate study report delivery and automatically generate SEND datasets.

Solutions Offered

• SEND Services: Includes SEND dataset preparation, SEND-ASSURE quality control of SEND datasets, and SEND quote generation for nonclinical regulatory submissions.
• Digital Study Report (DSR) Generation: Automated creation of digital study reports for nonclinical studies.
• Interim Monitoring of Nonclinical Studies: Supports ongoing oversight and monitoring of nonclinical study data.
• Interim Monitoring of Clinical Trials: Provides interim study monitoring capabilities for clinical trials compliant with regulatory standards.
• Automated SDTM Generation from EDC: Streamlines the conversion of EDC data into SDTM-compliant formats.
• Biosample Tracking for Specialty Assays: Manages and tracks biosamples associated with specialty laboratory assays.
• Clinical or Nonclinical Repository: Centralized, secure data repository for clinical and nonclinical study data.

Data Standardization and Quality Services

• SEND for Nonclinical: Full-service SEND dataset creation and compliance for nonclinical studies.
• SDTM for Clinical: Study Data Tabulation Model standardization services for clinical trial data.
• ADaM for Clinical: Analysis Dataset Model creation to support statistical analysis and regulatory submissions.
• Biomarker Assays: Data standardization services for biomarker assay data.
• SEND ASSURE and Corrections: Quality assurance review and correction services for SEND datasets.
• Data Concierge – Data as a Service: Managed data services for both nonclinical and clinical and translational research programs.
• Legacy Studies: Digitization, analysis, and warehousing of legacy clinical trial data to modernize historical study records.

Core Platform Capabilities

• Data Management and Curation: Efficient handling and organization of clinical and nonclinical data across the study lifecycle.
• Future-Proofed Warehousing: Secure and scalable data storage solutions designed to accommodate evolving regulatory and scientific requirements.
• Standardization and Harmonization: Ensures compliance with regulatory submission standards including CDISC, FDA, and PDMA requirements.
• Advanced Analytics and Visualization: Transforms raw study data into actionable insights through sophisticated analytical and visualization tools.

PointCross actively participates in key industry events, including the Society of Toxicology (SOT) Annual Meeting and ToxExpo and PHUSE US Connect, where the company presents on topics such as automating study report and SEND integration in nonclinical safety studies. By significantly reducing programming efforts for CROs and sponsors, PointCross aims to optimize current processes and enhance productivity across the global BioPharma data management landscape.