Category: Pivotal Inflection Articles

Driving Clinical Trial Success in CNS – Pivotal Phase 3 Study

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.

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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