Does the sponsor or the CRO pay for clinical trial insurance?

The sponsor holds the IND with FDA (or the equivalent regulatory submission with EMA, MHRA, etc.). The IND-holder bears the regulatory subject-protection obligation under 21 CFR Part 312 and parallel international regulations. The sponsor controls the protocol design, indication selection, dose escalation, stopping rules, and protocol amendments. The sponsor is the party responsible for subject safety arising from the trial intervention itself.

Clinical trial liability (CTL) responds to subject bodily injury arising from the trial intervention - the dose, the device, the surgical procedure. The party whose protocol caused the intervention is the right party to hold the coverage. That party is the sponsor.

The CRO carries professional liability and errors-and-omissions (E&O) sized to monitoring scope. This covers protocol monitoring errors, source document review failures, protocol-deviation reporting failures, and similar professional service failures the CRO is contractually responsible for under the sponsor MSA.

CRO E&O does not cover subject bodily injury arising from the underlying trial intervention - that exposure sits on the sponsor's CTL. The two coverages have different triggers and are not substitutes.

Some sponsor MSAs attempt to push clinical trial liability onto the CRO. Operationally this is backwards: the CRO does not hold the IND, does not design the protocol, and does not bear the regulatory subject-protection obligation. CRO E&O is structurally not the right vehicle for subject-injury claims arising from the protocol itself.

When this MSA language appears, the CRO should negotiate explicit boundary language: sponsor places per-trial CTL, CRO maintains monitoring-focused E&O. If the sponsor refuses to take CTL, the CRO needs sponsor backstop indemnity protecting the CRO from any sponsor-side claim that exceeds CRO E&O, plus CTL coverage purchased on the sponsor's behalf with the CRO as named insured (the cost of which gets passed through to the sponsor in the budget).

Best-practice CTA and MSA language explicitly addresses the boundary: (1) sponsor maintains per-trial CTL sized to phase, enrollment, geography, and indication; (2) CRO maintains professional liability and E&O sized to monitoring scope; (3) both parties are named as additional insureds on the appropriate policy; (4) claim-notification and defense-coordination procedures are documented; (5) indemnity flows align with policy coverage so neither party is uninsured for claims covered by the other policy.