Turning Rapid Study Start-Up Into Enrollment Momentum

For event-driven trials in rare diseases, enrollment pace isn't just an operational metric; it directly determines when a study can complete. That pressure intensifies when the eligible patient population is small, treatment alternatives are expanding, and the site network spans nearly 280 locations across 37 countries.

This case study details how a midsized biotech running one of the largest global Phase 3 cardiovascular outcomes trials in ATTR-CM addressed those compounding challenges through an integrated delivery model that aligned regulatory, clinical supply, laboratory, and operations functions around shared priorities from the outset. The result: first site activation 41 days faster than industry benchmark, 50% enrollment achieved eight months ahead of plan, and monthly accrual rates consistently 3–5x above forecast.

Examine the planning and execution approach behind those numbers.