How much does clinical trial liability insurance 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+.

CTL is usually placed as a stand-alone policy, not as an endorsement to general liability. The market is specialty - several US-domiciled life-sciences carriers and Lloyd's-backed surplus-lines syndicates - and generalist GL carriers rarely write the line.

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.