The ethics committee will not approve the protocol without it.
Liability cover for research on human subjects — required by ethics committees, sites and regulators before a trial can begin, and written per protocol rather than per year.
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What clinical trial businesses actually need.
Injury to trial subjects
Harm arising from participation in the study, whether or not anyone was negligent.
Without it — No ethics committee approves the protocol and no site will host it.
Protocol-specific limits
Written for the study, its phase, its subject numbers and the countries it runs in.
Without it — A general liability policy contemplates none of those and excludes the exposure.
Sponsor and investigator liability
Covers the sponsor, and the institutions and investigators running the study.
Without it — Sites require to be named before they will sign the clinical trial agreement.
Territorial extensions
Multi-country trials need cover recognized in each jurisdiction, several of which mandate local policies.
Without it — A trial that cannot start in one country holds up the whole program.
Where clinical trial shows up.
- Life Sciences
The study cannot start and the sites will not sign.
- Medical Devices
Required before the study can be approved.
- Pharmaceutical
No approval to run without it.
What clinical trial operators ask us.
When do we need it in place?
Before ethics submission, not before first dosing. The committee wants evidence of cover as part of approval, and sites will require it in the clinical trial agreement before they sign. Arranging it is also not instant — underwriters read the protocol, so build the lead time into the study timeline rather than discovering it in the approval queue.
What drives the price?
The protocol, in this order: phase, number of subjects, what is being studied, the population — paediatric, oncology and anything involving pregnancy rate very differently — and the countries. A first-in-human study is a different market from a phase IV observational one. Underwriters price the document rather than the company, which is why a well-written protocol with clear inclusion criteria is worth money.
Do we need separate cover in every country?
In several, yes. A number of jurisdictions require locally admitted policies and some set statutory minimum benefits or no-fault compensation schemes for trial subjects. A master policy with local admitted policies underneath is the usual structure for a multi-country study, and it takes longer to arrange than a single-country trial — start earlier than feels necessary.
Not ready to talk? The guides answer the questions this page raises in more depth. Already insured with us and need a certificate or a policy change? Ask the service team rather than starting a quote — it is faster and it goes to the people whose job it is. We also write home and auto, which is usually cheaper alongside the business policy than apart from it.