Leap21

Your clinical trials shouldn't depend on checking 6 websites.

AI-powered regulatory intelligence. Monitor 12 agencies with 4-hour alerts. From $499/month.

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FDA events (24h)
0
EMA decisions
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Safety signals
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Federal Register docs

What your regulatory team does today

Manual monitoring across multiple agencies, inconsistent alerting, missed critical signals

Today

  • ❌ Check 12+ agency websites daily
  • ❌ Manual risk assessment
  • ❌ 3-7 day alert delays
  • ❌ Missed cross-agency signals

With Us

  • ✅ Automated monitoring across 12 agencies
  • ✅ AI-powered risk assessment
  • ✅ 4-hour maximum alert delay
  • ✅ Cross-agency signal detection

See the regulatory landscape

Select a therapeutic area to see real-time regulatory intelligence

Regulatory Landscape

Elevated Risk
3
Active Clinical Holds
7
Warning Letters (30d)
5
Upcoming PDUFA
Safety Signals
12 active signals
Assessment

The oncology therapeutic area shows elevated regulatory risk due to recent FDA safety communications and clinical holds in similar indications. Two PDUFA dates approaching in Q2 2024 may impact competitive landscape.

FAERS Safety Signals

Drug Signal Type Events Severity
Pembrolizumab Cardiac toxicity 23
High
Nivolumab Hepatic injury 18
Moderate
Atezolizumab Infusion reactions 45
Low
Cemiplimab Immune-mediated pneumonitis 12
High
Ipilimumab Neurological events 8
Critical
Low
Moderate
High
Critical

Simple, transparent pricing

Choose the plan that fits your trial portfolio

Starter

$499/month
  • Up to 3 therapeutic areas
  • 1 regulatory site
  • Email alerts
  • Daily summary
Most Popular

Professional

$1,499/month
  • Up to 10 therapeutic areas
  • 5 regulatory sites
  • Email + Slack alerts
  • Real-time monitoring
  • API access

Enterprise

$3,999/month
  • Unlimited therapeutic areas
  • Unlimited sites
  • All alert channels
  • Dedicated support
  • Custom integrations

Built for

Phase I-III Clinical Trials

Get early access

Join the waitlist for the Regulatory Intelligence Agent. Limited spots available for early adopters.