XBIOM™  Metadata Repository, Smart Transformation, and eDataValidator

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: 

  1. 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.
  1. 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.  
  1. 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.