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.
Driving Clinical Trial Success in Rare Diseases A Global Phase 3 Study
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.
CRO Selection & Governance for a Phase 3 Asthma Program
Avillion, a late-phase therapeutic project partner accelerating market availability, required guidance for CRO selection across two clinical trials. With ambitious delivery timelines and multiple suppliers involved, Avillion needed both robust vendor selection and a governance framework to manage multiple CROs effectively.
Strategic Vendor Oversight and Trial Support for a Pivotal Phase 3 CNS Program
A small biotech company preparing for a pivotal Phase 3 trial in a challenging CNS indication had selected a CRO with deep therapeutic insight but limited experience in complex global delivery. The sponsor’s internal team was lean, with functional gaps in oversight, vendor coordination, and contract governance. When COVID-19 introduced added risk, the need for hands-on support became urgent. Seuss+ was brought in first to review a contract—then rapidly engaged to deliver fully integrated support across the trial lifecycle.
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