A privately-owned biotechnology company, backed by leading life science investors and over £270M in private financing, faced significant challenges running a global Phase 3 rare disease trial with a large CRO. With slow site activation, recruitment delays, and increasing board concerns over study feasibility, the sponsor engaged Seuss+ to restore confidence, accelerate timelines, and protect budget integrity.
Category: Risk Management Articles
Fully-Integrated Vendor Management Support in Phase 2
A high-potential biotech, entering Phase 2 with an ambitious formulation study, faced late-stage strategic changes that rendered its original CRO unsuitable. Operating with a lean team and under competitive pressures, the sponsor required rapid CRO transition, complete vendor oversight, and embedded operational expertise to stay on schedule and protect data integrity.
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