Contract Research Organizations · Texas
For CROs, the insurance conversation is mostly about three coverages.
Professional liability and errors and omissions, written on the right form for clinical or pre-clinical research services. Cyber liability sized for the volume of PHI and sponsor-confidential data your operation actually handles. Clinical trial liability — when sponsor MSAs unusually push the obligation onto the CRO instead of the sponsor.
The fourth conversation, less often discussed, is what happens at the boundary between your E&O and your sponsor's clinical trial liability when a subject injury claim arises. Coordination there is the difference between a clean sponsor relationship and a coverage fight.
Practice expansion in progress
Our CRO-specific content is rolling out over the next few weeks.
In the meantime, the MSA Decoder tool covers CRO-relevant clauses (clinical trial liability, professional liability, cyber, sponsor indemnity), and the practice already places programs for Texas-based clinical and pre-clinical CROs.
Frequently asked
Common questions from CDMO and CRO buyers
What insurance does a CRO need for sponsor MSA compliance?
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Three coverages cover most sponsor MSA requirements: professional liability and errors & omissions written for clinical or pre-clinical research services; cyber liability sized for the volume of PHI and sponsor-confidential data; and clinical trial liability when the MSA pushes that obligation to the CRO. General liability is also required but rarely the friction point.
Is a CRO's E&O the same as a CDMO's products liability?
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No. E&O covers errors in services (study design, data analysis, regulatory submission errors). Products liability covers physical harm from a manufactured product. CROs need E&O; CDMOs need products. Some hybrid CRO/CDMO operations need both.
How much cyber liability does a Texas CRO typically carry?
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Most clinical CROs carry $3M to $10M cyber, sized to the number of subjects, the sensitivity of PHI handled, and any sponsor-required minimums. Diagnostic and bioanalytical labs often need higher limits because of HIPAA exposure.
What is the boundary between sponsor and CRO clinical trial liability?
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The sponsor is typically the named insured on the trial-liability policy and the CRO is added as additional insured. The boundary fight happens when a subject injury claim alleges study-design or protocol-execution failure — that can land in the CRO's E&O instead of the sponsor's clinical trial coverage. Coordination language in the MSA and on the COI determines who pays first.
Do animal-only pre-clinical CROs need clinical trial liability?
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No. Pre-clinical / GLP toxicology work on animals does not require clinical trial liability. Animal-care liability (often a rider on GL) covers the animal subjects. E&O covers data integrity and study design.
How fast can a CRO add a sponsor as additional insured?
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Same-day to 5 business days for most carriers. Blanket additional-insured endorsements that auto-add anyone you contract with are available on most pharma-friendly E&O forms.