XBIOM Clinical Insights

XBIOM Clinical Insights is a clinical trial repository and visualization platform developed by PointCross Life Sciences, designed for biopharma R&D teams conducting clinical, translational, and biomarker research. The platform enables monitoring of ongoing and completed clinical trials by integrating electronic data capture (EDC) data with specialty biomarker assay results from patient bio-samples, supporting analysis and visualization in quasi-real time.

The solution is purpose-built for clinical researchers, data scientists, and translational teams who need to longitudinally integrate patient-level clinical endpoints with biomarker data, enabling deeper insights across trial arms and patient cohorts. It is part of the broader XBIOM™ Solutions Platform offered by PointCross Life Sciences.

Core Data Integration and Monitoring Capabilities

• Monitor ongoing clinical trial EDC data and specialty biomarker assays on patient bio-samples in quasi-real time.
• Longitudinal integration of EDC endpoints on individual patients with their corresponding biomarker data in near real time.
• Monitor individual patients for both safety and efficacy through an integrated longitudinal view encompassing dosing events, laboratory results, pharmacokinetic (PK) data, and biomarker data.
• Scan through tabulated subject-level data integrated across EDC, PK, and biomarker sources, along with curated notes.
• Access an overall study timeline view of the ongoing trial, including key events.
• Preconfigured monitoring tables and charts accessible directly from the study dashboard.

Cohort Building and Stratified Analysis

• Search, find, and visualize selected, highly stratified cohort data based on clinical endpoints, biomarker data, health history, concomitant medications, and other relevant data dimensions.
• Compare or cross-analyze data from various selected cohorts or trial arms to identify patterns and differences.
• Perform stratified search and cohort building to isolate specific patient populations for targeted analysis.
• Conduct customized statistical analysis of selected cohorts with the ability to save results as Tables, Figures, and Listings (TFLs) in a personal workspace.

Visualization and Collaboration Tools

• Access a complete suite of visualization tools to explore and present clinical and biomarker data.
• Extend analytical capabilities by adding custom analytics using R, Python, or other scripting languages.
• Collaborate with team members for insight generation, sharing analyses and TFLs within a shared workspace environment.

XBIOM Clinical Insights is part of PointCross Life Sciences' broader suite of biopharma R&D software solutions, which also includes tools for SDTM generation, biosample tracking, regulatory submission, and nonclinical study monitoring. The platform supports both ongoing and completed trials, making it applicable across the full clinical development lifecycle.