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.
Anaveon, a clinical-stage biotech backed by €140M+ in funding, was preparing to advance its lead immunotherapy asset into its first-in-human (FIH) trial. Despite a strong scientific foundation and recent Series A success, the internal team had limited operational experience and minimal exposure to CRO selection. With timelines tightening and strategic visibility increasing, the stakes were high: the right outsourcing decisions could set the tone for their clinical and investor trajectories.
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