Overcoming Patient Recruitment Challenges in a Pivotal Rare Disease Study
Summary
A privately-owned biotechnology company, backed by over £270M in private financing, was running a complex global Phase 3 rare disease study with strict inclusion criteria.
Nearly a year into recruitment, only 45 of 150 sites were activated and just 7 of 225 patients enrolled.
With increasing board concerns over trial feasibility, Seuss+ was brought in to stabilize recruitment and restore confidence in the study’s success.
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
Targeted Recruitment Intervention & CRO Performance Reset
Seuss+ worked directly with sponsor management to implement a structured action plan, improving site activation efficiency, accelerating recruitment, and renegotiating CRO accountability.
The Risk/Challenge
Significant delays in site activation and patient enrollment
Limited visibility of site-level communication and activation bottlenecks
CRO accountability gaps under existing contracts
Board concerns over study feasibility and impact of slow recruitment on milestones
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 the sponsor’s budget through renegotiated contracts
Board confidence in trial feasibility restored; milestone risks significantly reduced
How We Helped
Recruitment Gap Analysis: Reviewed patient enrollment and site activation processes, attended Investigator Meetings, and conducted interviews to identify bottlenecks and risks.
3-Month Action Plan: Implemented targeted solutions to address site activation inefficiencies and accelerate patient recruitment.
Clinical Study Plan Revision: Updated tools and processes to increase sponsor visibility on site-level communication, timelines, and resource allocation.
Contract & Change Order Negotiation: Amended contracts and renegotiated CRO terms to improve accountability and performance.
Frequently asked questions
Strict inclusion criteria on a rare-disease population, plus slow site activation, left the trial far behind after nearly a year.
We took hands-on vendor oversight of the recruitment effort, tightened coordination, and got sites and enrollment moving.
Monthly patient recruitment increased within three months of Seuss+ stepping in.
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Key takeaways
- The challenge: a global Phase 3 rare-disease trial stalled at 45 of 150 sites and 7 of 225 patients after almost a year.
- Seuss+ applied vendor oversight (VRMM optimization stage) to stabilize recruitment.
- Monthly patient recruitment climbed within three months and board confidence returned.
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