XBIOM Nonclinical Insights

XBIOM Nonclinical Insights, developed by PointCross Life Sciences, is a comprehensive nonclinical cross-study analytics and warehousing platform designed for biopharma R&D teams conducting safety and toxicology research. It enables longitudinal integration of disparate nonclinical study components into a centralized repository, supporting signal discovery, cohort identification, and in-depth analysis across single and multiple studies powered by a SEND data warehouse.

The platform is built for researchers and nonclinical scientists who need to search, visualize, and repurpose study data efficiently. By maintaining data in a Universal Data Model (UDM) with harmonized terminology and normalized units, XBIOM Nonclinical Insights ensures that data is consistently structured and readily available for downstream use, including the generation of SEND datasets and regulatory submissions.

Core Repository and Data Management Capabilities

• Longitudinal integration of disparate nonclinical study components into a unified repository for search and discovery of signals or cohorts based on specified criteria.
• Data loading and adaptors supporting both disparate data sources and standardized SEND datasets.
• Storage and maintenance of study data in a Universal Data Model with harmonized terminology and normalized units, enabling easy data repurposing.
• Support for generation of SEND datasets directly from the repository.
• Monitoring of interim data from ongoing nonclinical studies, enabling real-time visibility into study progress.

Analytics and Visualization Features

• Safety and toxicology analysis and visualization spanning both individual study and cross-study analytics.
• Histopathology & Necropsy vs Clinical Pathology: Analyzes histopathology and necropsy data in comparison with longitudinal or end-point clinical pathology results.
• Line Graph with Standard Deviation (Body Weight): Displays how values change over time, with lines representing group averages and error bars indicating standard deviation.
• Bar Graph with SD and Individual Data Points (Lab Findings): Compares group averages using bars with error bars for variation, while individual subject values are displayed as exploded data points to illustrate data spread.
• Z-Transformation (Liver Parameters): Visualizes changes in liver parameter values over time and enables comparison with a control group.
• Correlation Charts with Regression Lines: Displays relationships between selected parameters using linear regression lines.
• Correlation Chart (Liver Parameters): Calculates and presents correlation strength between parameters using both Pearson and Spearman statistical methods for comprehensive insight.

Histopathology Visualization Views

• Histopathology Consolidated View: Presents remarkable findings incidence organized by group, sex, and organ in a heatmap format.
• Histopathology Treemap View: Displays data as nested rectangles sized proportionally by the number of subjects affected per organ and finding.
• Histopathology Sunburst and Magnifier View: Enables interactive exploration of histopathology data in a circular format, with zoom-in features to reveal deeper levels of information.
• Histopathology Navigator View: Allows interactive viewing and understanding of data through navigator charts, where any selected dimension adjusts all related data in real time.

Insights Capture and Reporting

• XBIOM Insights enables researchers to capture findings by generating TFL (Tables, Figures, and Listings) objects with annotations for any selected cohorts.
• Generated TFLs can be saved for future access and publishing, supporting efficient reporting workflows.

XBIOM Nonclinical Insights is part of the broader XBIOM Solutions Platform from PointCross Life Sciences, which also encompasses modules for data curation, metadata management, regulatory submission, and clinical insights. The platform's SEND-compatible data warehouse and cross-study search capabilities make it well-suited for organizations seeking to maximize the value of their nonclinical study data across the drug development lifecycle.