As pulmonary fibrosis trials continue to expand globally, sponsors must navigate an increasingly complex operational landscape. Differences in regulatory expectations, site capabilities, patient access, and trial infrastructure across regions can significantly influence study timelines, enrolment success, and data quality.

Key Discussion Points Include:

• Navigating regional regulatory and ethics requirements, including how differing approval timelines, IRB/ethics committee expectations, and evolving regulations in emerging markets can impact global trial execution
• Strategies for identifying and activating high-performing sites, engaging investigators with varying levels of ILD expertise, and preventing under-enrolment or inactive sites across geographically diverse trial networks
• Managing the operational complexities of multinational trials, including drug distribution, cold chain logistics, imaging standardization, biomarker collection, and cross-border data integrity while maintaining compliance with GCP and regional privacy regulations
• Lessons from recent global IPF studies on designing scalable protocols, anticipating operational bottlenecks, and integrating hybrid or decentralized approaches to maintain efficiency without compromising data quality