A privately-owned rare disease biotech preparing for a global Phase 3 clinical trial faced significant contract challenges with its CRO. Misaligned terms created limited leverage to enforce performance, slow responsiveness to operational issues, and exposure to budget overruns. Seuss+ was engaged to renegotiate contracts, protect the sponsor’s position, and establish governance structures to hold the CRO accountable.
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.
A privately-owned biotechnology company, backed by over £270M in private financing, was running a complex global Phase 3 rare disease study with strict inclusion criteria. Nearly a year into recruitment, only 45 of 150 sites were activated and just 7 of 225 patients enrolled. With increasing board concerns over trial feasibility, Seuss+ was brought in to stabilize recruitment and restore confidence in the study’s success.
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.
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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