Articles tagged with “data-standards”

HL7 FHIR for Labeling: A Guide to the XML & SPL Transition

A comprehensive guide to transitioning from XML-based SPL to HL7 FHIR for e-labeling. Updated for 2026 with EMA go-live timeline, Jordan mandate enforcement, FDA PQ/CMC STU2, and latest FHIR adoption data.

45 min read

11/22/2025

hl7 fhir e-labeling pharmaceutical labeling healthcare interoperability regulatory compliance data standards

CDISC Standards: How They Work with SDTM & ADaM Examples

Learn about CDISC standards for clinical trial data. This guide explains SDTM, ADaM, CDASH, and Define-XML with concrete examples for regulatory submissions.

45 min read

11/14/2025

cdisc sdtm adam clinical trial data data standards regulatory submission cdash define-xml clinical data management