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 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.
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.
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