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Liability

Clinical Trial Insurance: Key Considerations for Sponsors

Sponsors and research organisations need trial-specific cover that matches the protocol, the sites and the requirements of approving bodies.

Why trial-specific cover matters

Clinical trial insurance responds to claims arising from injury to trial participants. Because every trial is different, the cover is usually arranged for a specific protocol rather than as a general liability policy.

Information insurers will request

Expect to share the protocol summary, phase of the trial, the investigational product, number of participants, trial sites and the planned duration.

Points to settle in advance

Confirm the insurance requirements of the ethics committees and authorities involved, the limits of indemnity required and whether follow-up periods after the trial are covered. Align the policy period with the full trial timeline, including any extensions.

This article provides general information only and is not advice on any specific policy or risk. Insurance is subject to terms, conditions, exclusions and applicable regulations.

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