Rescuing A Global Program For NDA Success

Veristat was engaged by a sponsor developing a Phase 3 combination therapy after the FDA raised concerns about their statistical analysis plans (SAPs). The feedback required substantial rework, including precise estimation definitions, handling of intercurrent events, and advanced missing data strategies. With tight deadlines and globally dispersed teams, The Veristat team re-authored the SAPs to meet FDA standards, integrated advanced statistical methods, and coordinated programming activities just before a scheduled database lock. Using a globally distributed team in Taiwan, Europe, and the U.S., Veristat ensured consistent data handling and analysis while providing strategic guidance and crafting high-quality regulatory documentation. They also supported FDA response packages, labeling language, and NDA submission.

The collaboration enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach that combined technical precision, regulatory strategy, and accelerated global execution.