The FDA now requires Diversity Action Plans before Phase 3. HelloStudys helps you recruit diverse patient populations with AI-powered matching and real-time demographic tracking.
Under FDORA, sponsors must submit Diversity Action Plans with enrollment goals by race, ethnicity, age, and sex before Phase 3.
Submit specific targets for underrepresented populations before Phase 3
Show FDA exactly how you'll reach diverse patient populations
Every month of recruitment delay costs an average of $8M
HelloStudys provides the complete toolkit sponsors need to meet FDA diversity requirements
Automatically screen patients against your I/E criteria before they reach sites
Collect age, sex, race, and ethnicity data to track enrollment diversity in real-time
Reach underrepresented communities through geo-targeting and community partnerships
Real-time reporting on enrollment demographics for your FDA submissions
Export audit trails and demographic breakdowns formatted for regulatory review
Enterprise security with BAA, encryption at rest, and comprehensive access controls
AI-powered study page with your I/E criteria built in
Smart pre-screener qualifies patients before they reach sites
Real-time diversity metrics for your FDA reporting
Pre-qualified, diverse patients delivered to coordinators
HelloStudys pages consistently outperform traditional recruitment
"The FDA diversity requirements caught us off guard. HelloStudys helped us build a recruitment strategy that actually reaches underrepresented populations - and we have the data to prove it to regulators."
Clinical Operations Lead, Phase 3 Oncology Trial
Get a personalized demo and see how HelloStudys can help you comply with FDA requirements