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Accelerating an ongoing Phase II trial
The Challenge
A rare disease Phase II study involving 20 participants across 7 sites in 3 countries had already missed its Last Patient In target twice.
Several sites remained unopened, genetic screening challenges were delaying recruitment and competitive pressures were increasing. The sponsor needed to understand the root causes of delay and identify practical actions to restore momentum.
The Approach
Rather than focusing on patients or sites, Science Enabled worked directly with sponsor stakeholders across clinical operations and supporting functions.
Structured interviews and facilitated workshops surfaced hidden barriers, challenged optimistic assumptions and enabled teams to build practical solutions around the issues most impacting delivery.
What we found
Three categories of internal optimisation emerged:
Ambition vs Reality
Timelines were built around best-case assumptions and lacked sufficient stress-testing against likely risks and delays.
Operational Complexity
Laboratory set-up, contracting, logistics and vendor management were repeatedly identified as major causes of slippage.
Accountability Gaps
Roles, responsibilities and performance monitoring lacked clarity, reducing the organisation's ability to identify and resolve issues quickly.
The Improvements
Clearer Accountability
Ownership was formally assigned across critical trial activities, creating greater visibility and faster decision-making.
Increased Operational Capacity
Resources were realigned to address contracting backlogs, logistics bottlenecks and site support requirements.
Performance Monitoring
Structured KPIs and RAG-based tracking were introduced to provide early warning of emerging risks and maintain delivery focus.
The Results
Trial performance challenges are not just driven by protocol design but also by organisational execution. By pre-empting hidden barriers and aligning teams around practical solutions, sponsors can accelerate delivery and retain control of study performance.
The sponsor realigned its internal trial operating model around clearer accountabilities, stronger performance management and enhanced operational capacity.
This enabled the team to resolve site challenges more quickly, clear delivery bottlenecks and improve trial execution without requiring a protocol amendment.
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.