Question
How much does clinical trial liability insurance cost?
Short answer
Phase 1 single-site CTL typically runs $15K-$50K per study. Phase 2/3 multi-site US scales to $50K-$150K. Global Phase 3 with EU sites or cell/gene therapy can exceed $200K. Pricing tracks phase, enrollment, geography, and indication risk.
What drives cost
Phase: pre-clinical < Phase 1 < Phase 2 < Phase 3. Each phase has materially more bodily-injury severity and longer claims tail than the prior phase, and pricing scales accordingly.
Enrollment: total subject count drives both incidence probability and aggregate exposure. A 2,000-subject Phase 3 study prices materially higher than a 200-subject Phase 2.
Geography: US-only is the cheapest baseline. EU sites trigger member-state-specific local insurance requirements (GCP compliance). Emerging markets add jurisdiction-specific compliance and severity risk.
Indication: oncology, rare disease, cell and gene therapy each carry materially higher severity multipliers. A general indication Phase 2 might price at $50K; the same study in cell therapy can price at $150K+.
Typical placement structure
CTL is usually placed as a stand-alone policy, not as an endorsement to general liability. The carriers writing the segment include AIG, Chubb, Liberty, AXA XL, and several Lloyd's syndicates with dedicated life-sciences underwriting.
For studies with EU sites, an EU-domiciled extension or fronting arrangement is required. Pure US placements do not satisfy EU member-state local insurance requirements.
Run the calculator at /tools/clinical-trial-liability-calculator for a directional estimate based on your specific study profile.
Related practice areas
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