Driving Clinical Trial Success in Rare Diseases A Global Phase 3 Study
Summary
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.
increase in monthly patient recruitment within 3 months
patients recruited per month sustained for 18+ months after engagement
saved in sponsor budget through contract renegotiations
What Seuss+ Delivered
Rebuilding Recruitment, Strengthening Oversight, and Restoring Confidence
Through a combination of targeted recruitment strategy, governance structures, and contract renegotiations, Seuss+ stabilized operations, restored sponsor-board confidence, and delivered measurable cost and timeline improvements.
The Risk/Challenge
Patient recruitment lagging, threatening critical milestones
Site activation rates slower than forecasted
Board-level concerns over study feasibility and funding impact
Lack of clear governance and escalation pathways with CRO
Contract terms limiting CRO accountability and financial flexibility
The Results
10x increase in monthly patient recruitment within 3 months
6–11 patients recruited per month sustained for 18+ months after engagement
£5M saved in sponsor budget through contract renegotiations
Board confidence in trial feasibility restored
Milestone timelines safeguarded
How We Helped
Recruitment Gap Analysis: Identified root causes, developed an action plan, and implemented solutions that increased recruitment rates and restored confidence in trial feasibility.
Governance Implementation: Installed a 3-tier governance framework with KPIs, clear escalation pathways, and inspection-ready documentation.
Change Order & MSA Negotiations: Renegotiated payment schedules and amended MSA terms to improve CRO accountability and strengthen the sponsor’s position.
Risk Management Setup: Created and managed a risk framework, facilitated Risk Committee meetings, and ensured transparency on key risks to protect strategic objectives.
Vendor Management Setup: Audited study systems and vendor lists, including subcontractors, to reduce study risk and enhance transparency.
Frequently asked questions
Slow site activation and recruitment delays on a complex global rare-disease trial raised board concern about feasibility.
We brought governance, risk management, and vendor oversight, and renegotiated where the contract left the sponsor exposed.
Rare-disease trials have thin patient pools and little room for error, so oversight and governance are what keep them viable.
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Key takeaways
- The challenge: a global Phase 3 rare-disease trial with a large CRO, slowed by site activation and recruitment delays.
- Seuss+ applied contract negotiation, governance, risk management, and vendor oversight.
- The work reached the pivotal inflection stage of the VRMM, protecting the trial and the asset.
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