XBIOM MDR

XBIOM MDR (Metadata Repository), developed by PointCross Life Sciences, is a robust and powerful solution for clinical and nonclinical data and metadata management. It is designed for biopharma R&D organizations that need to rigorously apply, govern, and validate industry standards across their data ecosystems. The platform serves as a centralized registry for both de-jure standards — such as CDISC SDTM, ADaM, CDASH, SEND, Protocol, and Define.XML — and de-facto client or CRO-specific standards and controlled terminologies.

XBIOM MDR is configured as an integrated suite of three core modules: the MDR ontology and repository, the Smart Transformer, and the eDataValidator. Together, these modules enable organizations to manage metadata standards governance, transform and map data at multiple organizational levels, and validate datasets against conformance rules — all within a single platform.

MDR Ontology and Repository Functions

• Comprehensive user management including authentication, authorization, security, permissioning, and roles and responsibility management to support Role-Based Access Control (RBAC).
• Workflow delegations of authority for governance and stewardship of standards and terminology codelists.
• Ontology viewers and editors for taxonomy (controlled terminologies) and standards management, covering both de-jure standards (CDISC SDTM, ADaM, CDASH, Protocol, Define.XML, SAP, SEND, and others) and de-facto standards such as those from clients, CROs, and specialty laboratories.
• Interfaces and APIs enabling enterprise and cross-enterprise integration and interoperability, including connectivity with clinical data layer solutions and Electronic Data Capture (EDC) systems.
• Workflow configurators and toolkits supporting maturation, phase-gated, and tethered workflows for the introduction of new standards and terminologies into enterprise MDR registries.
• Impact analysis capabilities and therapeutic area (TA) level customization for standards maturation.
• Validation and release management for new standards and terminologies prior to user deployment.
• Dashboard configurators designed for use in conjunction with governance workflows.

Smart Transformer Module

• Enables transformation of data or metadata for loading mapping libraries into the MDR registry.
• Supports data transformation for loading into the XBIOM UDM Repository at multiple organizational levels: global, therapeutic area, R&D program, and individual study levels.
• Facilitates export of study data from the UDM and Data Services Layer — including analysis-ready metadata — to SDTM or ADaM formats.
• Includes associated tools for Define.XML, TS.XML, and Trial Design Editors to support regulatory submission readiness.

eDataValidator Module

• A dedicated validator engine that tests and ensures any metadata model conforms to the applicable standards and their expected conformance rules.
• Supports validation of all standard datasets produced through the XBIOM platform.
• Extensible to cover client-specific de-facto customized standards, providing flexibility beyond industry-standard rule sets.

XBIOM MDR is part of the broader XBIOM Solutions Platform offered by PointCross Life Sciences, which also encompasses modules for virtual data rooms, study data ingestion and curation, unified data management, regulatory submission, and clinical and nonclinical insights. The platform is built to integrate with enterprise systems including EDCs and clinical data layers, making it suitable for organizations seeking end-to-end metadata governance and data standardization across their clinical and nonclinical research operations.