TFS HealthScience has demonstrated its specialized capabilities in ophthalmology clinical trials through successful execution of two complex studies: a multinational Phase IIb geographic atrophy trial and a time-sensitive Phase III dry eye disease study. Both trials showcase the company's ability to navigate operational complexities while maintaining rigorous scientific standards in specialized therapeutic areas.
Geographic Atrophy Trial Spans Seven Countries
The Phase IIb study investigated a novel pegylated RNA adapter for geographic atrophy secondary to dry age-related macular degeneration, conducted across 78 sites in seven countries. The trial required specialized capabilities in retinal imaging, visual function testing, and intravitreal administration procedures.
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. The company's adaptive project management approach accommodated mid-study shifts in strategy, expanding site networks without delaying activation timelines.
A proactive COVID-19 risk mitigation plan included remote monitoring and alignment with evolving regulatory guidance, ensuring 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.
Rapid Execution in Dry Eye Disease Study
TFS was engaged to manage a time-sensitive Phase III trial in dry eye disease with rigid timelines and ambitious development goals. The study required rapid activation of 25 U.S. sites, enrollment of 250 patients within six weeks, and final top-line results within three weeks of study completion.
Primary endpoints included changes in SANDE scores and Lissamine Green conjunctival staining at Days 14 and 28. TFS met these aggressive goals through precision project management, leveraging strong site relationships, ophthalmology-specific expertise, and data-driven site selection.
Historical performance metrics and trusted partnerships enabled accelerated feasibility, reduced risk, and improved responsiveness. A cohesive full-service team ensured close coordination across clinical operations, monitoring, data management, and biostatistics.
Operational Excellence in Specialized Therapeutics
Both trials highlight TFS's capacity to execute critical studies efficiently in specialized therapeutic areas through expert leadership and strategic operational planning. The company's ophthalmology-specific expertise proved essential in managing complex imaging protocols and specialized procedures required for retinal disease studies.
The successful completion of these trials, particularly the advancement of the geographic atrophy program to Phase III, demonstrates TFS's ability to deliver high-quality results while minimizing sponsor oversight and streamlining execution processes. The sponsor benefited from minimized feasibility costs and improved confidence in advancing their ophthalmology pipeline.
