Navigating Complexity: TFS's Tailored Solutions For A Global Phase III Neovascular AMD Study

A Phase III combination study for neovascular age-related macular degeneration (AMD) was initiated by a small U.S. biotech company to evaluate the safety and efficacy of an investigational intravenous therapy. Given the study’s complexity—strict eligibility criteria, specialized diagnostic equipment, and precise treatment protocols—TFS HealthScience (TFS) played a critical role in ensuring its success. The study expanded across 16 countries, requiring TFS to navigate intricate regulatory landscapes, optimize site selection, and streamline trial operations.

TFS implemented a tailored strategy to address key challenges, including a high screen failure rate, strict masking procedures, and extensive site certification procedures. By leveraging a phased feasibility strategy, TFS facilitated seamless study expansion and site grandfathering, ensuring compliance and operational efficiency. Additionally, patient-centric measures, such as flexible screening periods and travel support, improved retention in an older patient population. To maintain study momentum, TFS deployed contingent clinical research associates (CRAs) and conducted proactive data management planning, ensuring sites remained engaged and prepared for a critical 12-month interim analysis.