Better Health Through Community Engagement

Patient Navigation and Engagement Services

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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?