How it Works
1. Review
Review library of past FDA decisions
2. Simulate
Simulate design tradeoffs relevant for your clinical development program
3. Collaborate
Securely share your plan internally and externally with regulators, experts, patient groups, and other stakeholders
Innovative Trial Design
Understand the effect of innovative design elements
External Control Arms
Considering Real World Data to reduce or eliminate patients taking a placebo?
Decentralized Trials
Considering embracing patient optionality to not go to a site and be treated from home?
Diversity
Considering sub-populations?
Endpoint selection
Considering multiple endpoints?
Plus Many More
Considering another design?
