One governed home for every standard and codelist
The XBIOM™ Metadata Repository rigorously applies all standards in its registry through the Smart Transformer, and validates every standard dataset with the eDataValidator.
Repository, Transformer, and Validator
Xbiom-MDR (Metadata Management and Repository) brings standards governance, data transformation, and conformance validation into one connected system.
Govern every standard and terminology codelist
A single registry for ontology and standards management, with the controls that keep stewardship and governance in the right hands at every step.
- ✓ Role-Based Access Control for user management, authentication, authorization, permissioning, and workflow delegations of authority in standards governance and stewardship
- ✓ Ontology viewers and editors for taxonomy (CTs) and standards (e.g. IG) management across de-jure and de-facto standards
- ✓ Interfaces and APIs for enterprise and ex-enterprise integration, such as clinical data layer solutions and EDCs
- ✓ Workflow configurators for maturation, phase-gated and tethered workflows, impact analysis, TA-level customization, validation and release
- ✓ Dashboard configurators for use with each governance workflow
Map, transform, and load at any level
The Smart Transformer transforms data or metadata to load mapping libraries into the MDR registry, or to load data into the UDM Repository at a global, therapeutic-area, program, or study level.
- ✓ Transform data or metadata to load mapping libraries into the MDR registry
- ✓ Load data into the UDM Repository at global, TA, program, or study level
- ✓ Export study data from UDM and the Data Services Layer, including analysis-ready metadata, to SDTM or ADaM
- ✓ Associated tools for Define.xml, TS.XML and Trial Design editing
Prove every model conforms to the standard
eDataValidator is a validator engine that tests and ensures any metadata model conforms to the standards and the conformance rules expected of such a standard. These checks can be extended to cover a client’s de-facto customized standards.
- ✓ Tests that any metadata model conforms to its registered standard
- ✓ Applies the conformance rules expected of each standard
- ✓ Extensible to cover a client’s de-facto customized standards
- ✓ Works in concert with the MDR registry and Smart Transformer outputs
De-jure and de-facto, in one registry
The MDR manages published industry standards alongside the customized standards your organization, CROs, and specialty labs work to every day.
Published industry standards
Governed, versioned, and released to study teams as the authoritative source for clinical and nonclinical submissions.
Your customized standards
Client, CRO, and specialty-lab standards and controlled terminologies are matured into the registry through the same governed workflows.
Transform and load at the right scope
The Smart Transformer loads data into the UDM Repository at the level that fits your governance, from enterprise-wide down to a single study.
Enterprise level
Apply standards and mapping libraries consistently across the entire organization.
Therapeutic area
Customize transformations for the conventions of a specific therapeutic area.
R&D program
Align data across the studies that make up a single research and development program.
Study level
Transform and load data for an individual study, ready for export and submission.
Export study data from UDM and the Data Services Layer, including analysis-ready metadata, straight to SDTM or ADaM with associated authoring tools.
Key terms & acronyms
The vocabulary used across the XBIOM Metadata Repository, Smart Transformer, and validation workflows.
Metadata Management and Repository for governed standards and terminology
Role-Based Access Control for governance, stewardship, and delegations of authority
Controlled Terminology codelist used across standards
Implementation Guide for a published data standard
Unified Data Model repository where transformed study data is loaded and stored
Therapeutic Area, a level for customizing standards and transformations
Clinical Data Acquisition Standards Harmonization for data collection
Statistical Analysis Plan defining how study data will be analyzed
Study Data Tabulation Model for clinical submission datasets
Analysis Data Model for analysis-ready clinical datasets
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