Accelerating A Complex Global Cardiovascular Outcomes Trial Through Coordinated Execution

For a mid-sized biotech with a rare disease background, executing a cardiovascular outcomes trial across 1,500 sites in 35 countries and involving 11,000 patients represented the most complex undertaking in its history. Because event accumulation determines the duration of an outcomes trial, accelerating site activation and patient enrollment was critical.

However, accelerating site activation and enrollment also meant ensuring investigational products and lab kits were ready when needed. By integrating CRO, clinical supply, and central laboratory services, the delivery model helped teams identify potential milestone delays early and adjust plans accordingly. Adaptive forecasting kept product and kit availability aligned with the pace of site activation, helping avoid supply gaps as the study progressed. The analysis compares site activation and enrollment against the original plan and industry benchmarks, showing how the trial performed against expectations. It also quantifies the laboratory kit waste avoided through adaptive forecasting.

Read the full results to explore the impact on activation, enrollment, and kit waste.