What insurance does a CRO need?

A clinical research organization (CRO) typically needs five core coverage lines plus any additional coverage demanded by sponsor MSAs in the active book.

Clinical trial professional liability (E&O): the primary exposure for a CRO. Coverage responds to claims arising from trial-design errors, protocol-execution failures, sponsor indemnity assumed by contract, and investigator-initiated study exposure. Mid-market CROs typically need $5M-$10M.

Cyber liability for PHI under HIPAA: any CRO handling patient PHI from clinical sites needs explicit Business Associate coverage. The Sturm-recommended structure for a CRO at $5M-$20M revenue is a $3M-$10M cyber tower.

Products liability where research-output deliverables apply: CROs delivering characterized samples, validated assays, or reference standards face products liability for those deliverables in addition to professional liability for the underlying services.

Sponsor MSA insurance schedule compliance: every sponsor MSA has its own insurance schedule that the CRO must satisfy continuously. The CRO needs disciplined risk-management infrastructure to track schedule demands across the active sponsor portfolio.

D&O for the operating entity: standard architecture sized to investor and governance exposure.