TFS Drives Global Start-Up For Multinational Geographic Atrophy Trial

In a Phase IIb study investigating a novel pegylated RNA adapter for geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), a leading biopharmaceutical company partnered with TFS HealthScience to navigate the operational and therapeutic complexities of a multi-country ophthalmology trial. Conducted across 78 sites in seven countries, the trial required specialized capabilities in retinal imaging, visual function testing, and intravitreal administration. TFS leveraged its deep ophthalmology expertise and longstanding global site relationships to ensure readiness and compliance with demanding imaging protocols, including spectral-domain OCT and fundus autofluorescence assessments. Through adaptive project management, TFS accommodated mid-study shifts in strategy, expanding site networks without delaying activation timelines.

A proactive COVID-19 risk mitigation plan, including remote monitoring and alignment with evolving regulatory guidance, ensured uninterrupted patient safety oversight and data quality. Despite dynamic trial conditions, TFS delivered full-service clinical operations with minimal sponsor oversight, supporting successful study execution and advancing the program to Phase III. This outcome highlights TFS’s capabilities in risk planning, trial agility, and ophthalmology-specific execution across geographically and operationally diverse settings.