XBIOM™ Metadata Repository rigorously applies all Standards in its registry through Smart Transformation and validates all standard data sets with the eDataValidator
Xbiom-MDR (Metadata Management and Repository) is configured with three modules:
- MDR ontology and repository functions:
- User management, authentication, authorization, security, permissioning, roles and responsibility management used for Role-Based Access Control (RBAC) and workflow delegations of authority in governance and stewardship of standards and terminology codelists.
- Ontology, viewers and editors for taxonomy (CTs), and standards (e.g. IG) management for de-jure (CDISC SDTM, ADaM, CDASH, Protocol, Define.XML, SAP, SEND etc.) and de-facto (Client or CRO, Specialty Labs) standards and CTs.
- Interfaces and APIs for enterprise and ex-enterprise integration and inter-operation, such as clinical data layer solutions or EDCs.
- Workflow configurators and toolkits for maturation, phase-gated and tethered workflows for maturation of new standards/Terminologies into the enterprise MDR registries, impact analysis and TA level customization, validation and release to users.
- Dashboard configurators for use with workflows.
- Smart Transformation module for transformation of data or metadata for loading mapping libraries into MDR registry, or transforming data for loading into UDM Repository at a global level, at a Therapeutic Area, at a R&D Program Level, or at a Study Level. Export study data from UDM and Data Services Layer (including analysis ready metadata) store to SDTM or ADaM with associated tools for Define.xml, TS.XML and Trial Design Editors.
- eDataValidator is a validator engine that test, or ensure, that any metadata model conforms to the standards and the conformance rules expected of such a standard. These can be extended to cover Client’s de facto customized standards.