XBIOM UDM

XBIOM™ UDM (Universal Data Model Repository), developed by PointCross Life Sciences, is a centralized, future-proofed data repository designed to hold all study data managed within the XBIOM platform. Study data is normalized to a simple data model and harmonized to a global terminology set that is mapped to de jure controlled terminology used when exchanging data with external agencies. The repository is purpose-built for life sciences organizations — including large BioPharma companies — managing complex, multi-study datasets across the full research and development lifecycle.

XBIOM UDM serves as the keystone of the entire lifecycle of clinical and study data, supporting ad hoc research for insights, submission-ready standardization, and exploratory research spanning legacy studies through to ongoing trials. It is particularly valuable when biomarker data is longitudinally integrated with patient in-vivo data from clinical trials, enabling richer translational research and safety analysis.

Supported Study and Data Types

• In-vitro and specialty assays derived from bio-banked biosamples
• In-vivo animal study data from nonclinical safety studies
• Clinical trial data across all phases
• Large volumes of specialty biomarker assay data, including genomics, cell phenotyping, immune-markers, and histopathology

Core Data Model Capabilities

• Longitudinal representation of as-collected data, preserving the original study record over time
• Support for an unlimited number of metadata and derived metadata attributes alongside core study data
• Normalization to a simple, consistent data model that accommodates diverse data types and sources
• Harmonization to a global terminology set mapped to de jure controlled terminology for regulatory data exchange
• Future-proofed architecture designed to evolve with changing data standards and research needs

Search and Query Features

• Indexed repository enabling efficient search query execution across large and complex datasets
• Query masks that can cover disparate data domains within a single search
• Support for hierarchical query structures that can be recursively applied to evolving repositories
• Planned and ad hoc access patterns supported, accommodating both routine reporting and exploratory research

Standardization and Regulatory Submission Support

• Enables submission-ready data standardization using CDISC SDTM for clinical data
• Supports ADaM dataset generation for clinical analysis
• Facilitates transformation of as-collected data for exchange with external regulatory agencies
• Serves as the foundation for downstream regulatory submission workflows within the broader XBIOM platform

XBIOM UDM operates as an integral component of the XBIOM Solutions Platform from PointCross Life Sciences, working in concert with modules such as the VDR for study data ingestion and curation, the MDR Smart Transformer, and the XBIOM Regulatory Submission module. It supports both nonclinical and clinical data use cases, making it a versatile enterprise repository for BioPharma R&D organizations managing data from legacy studies through to active clinical programs.