What is clinical trial professional liability for CROs?

Clinical trial professional liability - more precisely Errors and Omissions (E&O) coverage tailored to CRO services - is the primary insurance exposure for a CRO. The coverage responds to claims arising from trial-design errors, protocol-execution failures, statistical analysis errors, sponsor indemnity assumed by contract, and investigator-initiated study exposure.

The distinction from clinical trial liability (sponsor-side bodily injury coverage) is structural: clinical trial liability covers subject injury claims; CRO professional liability covers errors in the CRO's service delivery. Both exist; both are needed; they are not substitutes.

Mid-market CROs typically need $5M-$10M E&O. The driver is the sponsor indemnity assumed under active CTAs - sponsors typically require the CRO to indemnify for service-related errors at the CRO's service fee multiplied by some factor, and the E&O program needs to fund that exposure.

Larger CROs serving multinational sponsors typically need $10M-$25M with explicit international jurisdiction coverage, including admitted-paper local policies for EU clinical trial activity.