AI-Powered Clinical Study Design
AI-Powered
Clinical Study Design
Randomized Control Studies
Design smaller, faster, highly-powered randomized trials that leverage digital twins to reduce sample sizes without sacrificing power. Alternatively, use digital twins to boost trial power without adding additional trial participants. This approach is qualified by the EMA and aligns with current FDA guidance.
Single-Arm Studies
Generate digital twins as a simulated control group in single-arm studies, enabling precise treatment effect analysis for the trial. This provides a robust comparator group without needing a traditional or externally matched control arm.
Multiple Ascending Dose (MAD) Studies
Design a MAD study using digital twins to accelerate the timeline for determining the safety, tolerability, and optimal dose ranges, allowing for quicker progression to later trial phases or go/no-go decisions.
