Clinical development rarely goes as planned. When recruitment slows, assumptions shift, or new scientific insights emerge, teams must quickly determine whether their study is still designed to succeed. In this case study, you’ll see how a global sponsor confronted this challenge mid-trial and avoided costly delays and underpowered outcomes.

This resource showcases how MMS experts used KerusCloud®, a simulation-guided design platform, to reassess the Probability of Success (PoS) under new constraints, including a larger-than-expected treatment effect and recruitment disruptions during the COVID-19 pandemic.

Ideal for clinical operations leaders, statisticians, program managers, and early development teams, this case study demonstrates how modern simulation tools can de-risk decision-making even after a trial has begun.

Key Benefits / What You’ll Learn:

• Analyze how real-world disruptions (like COVID-19) can impact original sample size planning.
• Uncover hidden design assumptions including biomarker correlation and data truncation that can dramatically shift study outcomes.
• Quantify Probability of Success (PoS) across multiple recruitment and effect-size scenarios.
• Evaluate alternative study designs to reduce patient burden while maintaining robust statistical power.
• See how interactive simulation heatmaps reveal key drivers of study success within minutes.

Created by MMS early-development statisticians and simulation experts leveraging KerusCloud®, a proven platform trusted by global sponsors for de-risking clinical programs.