A privately-owned clinical-stage biotechnology company, focused on developing therapies for CNS indications, faced the high-stakes challenge of running a pivotal Phase 3 clinical trial for its lead asset. Partnering with a small CRO experienced in the disease area but inexperienced in complex global trials posed significant risks to operational delivery and future asset value. Seuss+ was engaged to optimize vendor alignment, governance, and inspection readiness to ensure trial success.