When does a biotech need clinical trial liability insurance?

A biotech sponsor needs clinical trial liability (CTL) coverage in place before the IND opens and before any clinical trial agreement (CTA) is signed with an investigative site. CTL responds to subject injury claims arising from the trial - the principal liability a sponsor carries during a study.

Coverage is typically structured as a stand-alone policy with limits scaled to study phase, enrollment, and geographic scope. Phase I single-site US studies often place at $5 million; Phase II/III multi-site US studies typically require $10 million to $25 million; global studies with European Union sites require an EU-domiciled extension because EU GCP requires local insurance compliance.

CTAs almost always require the sponsor to name the investigative site, the principal investigator, and the institution as additional insureds, and to indemnify them for trial-related claims. The sponsor cannot ethically or contractually shift this liability to the CRO; the CRO's professional liability is a separate coverage that responds to its own service errors, not to subject injury.