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Delivering an ambitious phase III study
The challenge
A rare disease Phase III study required 1,177 participants across 330 sites in 30 countries.
With a forecast duration of more than 52 weeks, complex and demanding procedures and significant symptomatic patient burden, the sponsor needed to address participation barriers before they impacted performance.
The Approach
Science Enabled engaged patients, caregivers and sites through structured research and advisory council programmes, translating real-world experience directly into protocol and operational improvements.
The Improvements
Input from patients, caregivers and sites informed meaningful protocol and operational adjustments:
Simplified Protocol
Fewer visits and procedures, wider visit windows and options for at-home assessments.
Enhanced Participant Support
Travel concierge services, caregiver stipends and caregiver-specific materials.
Reduced Site Burden
Harmonised vendor structures and streamlined processes.
Improved Site Resources
Tailored visit checklists for complex study coordination.
Sustained Engagement
Regular calls and town halls to maintain awareness and momentum.
The Results
Recruitment rate
54%
faster than industry average
87%
Remained on treatment
vs target >80%
10%
permanently discontinued
vs target <20%
Ready to improve your trial design?
Whether you are in early protocol development or managing a challenging recruitment situation, we would be delighted to hear from you.