Xbiom for Clinical Metadata Management and Repository (MDR)

Xbiom is a robust, powerful solution for a Clinical, and Nonclinical Data and Metadata Repository.

Xbiom-MDR (Metadata Management and Repository) is configured with three of its core modules:

  1. The foundational Metadata and Ontology platform functions which include:
    • User management, authentication, authorization, security, permissioning, roles and responsibility management used for access and workflow delegations of authority
    • Ontology, taxonomy, and standards 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
    • Workflow configurators and toolkits for maturation, phase-gated and tethered workflows
    • Dashboard configurators for use with workflows
  2. Smart Transformation module for ingestions, curation, and transformation of data or metadata for loading and use in the MDR; and for exporting specifications and other metadata models at a global level, at a Therapeutic Area, at a R&D Program Level, or at a Study Level.
  3. eDataValidator is a validator engine that can 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 over Client’s de facto customized standards.