What is the difference between CRO and CDMO insurance?

CRO and CDMO insurance programs are structurally different because the products are different. A CRO delivers research and clinical trial services; the primary exposure is professional liability (E&O) for service-related errors. A CDMO delivers manufactured product; the primary exposure is products liability for product-related claims.

CRO program emphasis: clinical trial professional liability ($5M-$10M), cyber for clinical PHI and DMF data flows ($3M-$10M), sponsor MSA-required additional lines, D&O, EPL. Products liability is a smaller line where research-output deliverables apply.

CDMO program emphasis: products liability ($5M-$10M for small molecule, $10M-$25M for biologic or sterile injectable), cGMP property with validation extension, dedicated recall coverage ($1M-$5M), professional liability for development services ($2M-$5M), cyber for sponsor DMF and clinical data flows.

Both need sponsor MSA-driven additional-insured architecture - sponsor as additional insured, primary and non-contributory wording, waiver of subrogation, 30-day notice of cancellation - but the underlying coverage that supports those endorsements is different.

Operators that span both services (development services plus contract manufacturing) need both program shapes in coordination.