NGSI-LD as a Context Management Layer for CDISC 360i: Linking Standards Without Replacing Them

About this session

Part of Session 3, Track B: Digital/AI Foundations (Chair: Srinivasa Rao Mandava, Merck).

CDISC 360i calls for standards implemented as linked metadata with semantic relationships enabling end-to-end automation. The foundational standards are strong. What is missing is a context management layer that connects them at runtime with provenance, temporal versioning, and federated discoverability. NGSI-LD, an open ETSI standard adopted across digital twins and federated data ecosystems worldwide, provides exactly this layer. Its information model represents entities as property graphs with first-class relationships encoded in JSON-LD. Its context broker architecture supports dynamic discovery, subscriptions, and temporal queries, capabilities that map directly onto 360i requirements. This presentation shows how NGSI-LD can serve as connective infrastructure for CDISC standards without modifying them, demonstrates a biomedical concept traversing from USDM through SDTM and ADaM as linked entities, and explores practical alignment with all standards.

Speakers

• BL

  Bo Lora

  Independent

  Speaker

• SM

  Srinivasa Rao Mandava

  Merck

  Chair