Articles tagged with “hl7-fhir”

eCTD v4.0 Explained: Implementation & Global Timelines

Guide to eCTD v4.0 regulatory submissions. Learn about HL7 FHIR standards, document reusability, and global implementation deadlines for FDA and EMA.

40 min read

2/25/2026

ectd v4.0 regulatory submissions hl7 fhir ich guidelines fda compliance rps standards ema implementation pharma data standards

Veeva CRM and Epic EHR Integration: A Technical Guide

Explore the technical and regulatory aspects of Veeva CRM and Epic EHR integration. Covers FHIR standards, HIPAA compliance, and data exchange strategies.

40 min read

2/12/2026

veeva crm epic ehr healthcare interoperability hl7 fhir data integration life sciences technology hipaa compliance clinical trial data patient data exchange

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. Learn the key benefits, regulatory requirements, and steps for team readin

40 min read

11/22/2025

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

HL7 FHIR Guide to eSource & ePRO Interoperability

Learn about clinical data interoperability with this updated guide to HL7 FHIR (R5/R6), eSource, and ePRO. Covers ICH E6(R3), FDA FHIR initiatives, standards, use cases, and challenges in modern research.

40 min read

11/11/2025

hl7 fhir esource epro healthcare data standards electronic health records clinical research data smart on fhir