How does CRO professional liability differ from products liability?

CRO professional liability and errors-and-omissions (E&O) responds to claims arising from the CRO's service-delivery errors: protocol monitoring failures, source document review errors, eCRF data integrity errors, regulatory submission errors, and similar service-side defects. The damages covered are typically pure economic loss to the sponsor (lost trial value, delayed approval, additional study costs) - not bodily injury to subjects.

Products liability for a CRO responds to claims arising from bodily injury or property damage caused by products. The exposure is more limited for CROs than for CDMOs because CROs typically do not manufacture or distribute products - but laboratory CROs that produce bioanalytical samples, central labs that distribute kits, and CROs that handle investigational product distribution all have meaningful products exposure.

The gap between the two that catches operators: professional liability typically excludes bodily injury, and products liability typically excludes pure economic loss. A claim that straddles both (e.g., a CRO data integrity error leading to a flawed sponsor regulatory submission and downstream patient injury) requires both policies to respond in coordination - and the boundary handling between the carriers is one of the harder things to coordinate at claim time.