Clinical trial insurance for sponsors, CROs, biotech, and investigator-sponsors.

Clinical trial insurance (also called clinical trial liability or CTL) covers subject bodily injury or death arising from the trial intervention, the sponsor's contractual indemnity to investigators and sites under the clinical trial agreement (CTA), defense costs and expert witness expense for trial-related litigation, regulatory defense for FDA / EMA / MHRA inquiries triggered by a trial event, and (with the right endorsement) subject compensation for trial-related injury on a no-fault basis under CTA or NIH OHRP guidance. EU site exposure also requires EU Clinical Trials Regulation (CTR) compliant insurance in each member state.

First-in-human and Phase 1 trials baseline at $5M-$10M per trial; biologics and gene therapies push to $10M-$25M. Phase 2 baselines at $5M-$10M with oncology and rare disease typically $10M-$15M. Phase 3 baselines at $10M-$25M with pivotal oncology, gene therapy, or EU-site trials typically $25M+. Investigator-sponsored trials usually $3M-$10M with AMC self-insurance coordination. Sizing tracks site count, total enrollment, geographic spread (especially EU CTR mandatory compliance), indication severity, and dose-response toxicity profile.

Premium scales with the limit purchased, indication, trial scale, and geography. Early-phase domestic trials at $5M limit typically run $15,000-$50,000 per trial. Phase 3 oncology with EU sites at $25M limit can run $150,000-$500,000 per trial. The Clinical Trial Liability Calculator on this site returns a coverage-need band; pricing is sized against that band and the sponsor's claims history.

The clinical trial insurance market is a narrow specialty - a handful of carriers globally write the bulk of large-scale CTL with EU CTR capability. Specialty life-sciences underwriters at admitted carriers and Lloyd's-backed surplus-lines paper cover most of the market. Generalist commercial carriers typically do not write CTL beyond very small Phase 1 trials, and even there the coverage forms can leave gaps for protocol-driven injury vs monitoring error. A specialty broker accesses the right carrier panel.

Yes - investigator-sponsored trials at academic medical centers typically coordinate three layers: the AMC self-insurance trust (primary, covers AMC investigators and AMC sites); standalone clinical trial liability with the IST investigator as named insured (covers external sites and multi-center IST coordination); and an industry sponsor backstop indemnity layer where the trial is industry-funded. The AMC self-insurance often does not extend to external sites or industry-funded protocols, which is why standalone CTL is load-bearing.

No. The sponsor MSA insurance schedule is the list of coverages the sponsor requires the CRO to maintain (typically CGL, products, professional liability/E&O, cyber, workers comp). Clinical trial liability is a separate placement that sits with the sponsor (or IND-holder) and covers subject injury arising from the trial intervention. The CRO's professional liability covers monitoring errors but does not respond to protocol-driven subject injury - that is the sponsor's clinical trial liability.

Only with explicit EU CTR endorsement or local-admitted paper in each EU member state. The EU Clinical Trials Regulation (No 536/2014) requires sponsors to maintain insurance or indemnification covering trial sites and subjects in every EU member state where a study is conducted. US-only clinical trial liability does not satisfy this - the placement needs a global program with country-specific endorsements or local-admitted policies issued by carriers licensed in each country. Compliance documentation must be in place before the EU site IRB / ethics committee approval.

Massachusetts anchors the largest US clinical trial cluster - Cambridge, Boston, Worcester host hundreds of active sponsor trials at AMCs (MGH, BIDMC, BWH, Dana-Farber, Boston Children's) and at sponsor-funded sites. The MA market is also a leading entry point for EU-headquartered sponsors entering the US, which adds EU CTR coordination requirements. Massachusetts trial sites and sponsors operate at scale where generalist programs commonly under-place CTL.

Always - if the underlying policy is claims-made (which most CTL is). Subject injury claims can surface years after trial close-out, particularly in gene therapy (5-15 year latency) and oncology (multi-year survival cohort follow-up). Without an extended reporting period endorsement purchased at close-out, the expired claims-made policy does not respond to late-reported claims. Tail pricing scales with indication and trial scale; gene therapy tail is materially more expensive than oncology, which is more expensive than cardiovascular.