Australian sponsors and research businesses organising trials with Australian or overseas participants.

Where the sector’s exposures differ

Sponsor, CRO, site and investigator responsibilities differ. A sponsor’s trial liability policy, a CRO’s professional indemnity and a treating clinician’s medical indemnity should not be treated as interchangeable. Countries, protocols, trial phases and participant numbers materially affect underwriting.

Insurance covers to assess

Review participant injury and compensation arrangements, negligent acts, contractual indemnities, insured parties and local policy requirements. Overseas trials may need locally admitted policies or specific certificates. Do not assume that an Australian policy covering overseas territories satisfies every country’s legal or site requirements.

Policy features to discuss

We can discuss the insured activities, insured entities, territorial limits, defence costs, excesses and aggregate limits offered by insurers. If a customer requests particular insurance, let us know so we can consider the available cover. Legal interpretation, drafting and negotiation of contracts should be handled by your legal adviser.

An illustrative exposure

An Australian sponsor runs a study at an overseas site. A participant allegation raises questions about the local policy, site indemnity and sponsor’s programme.

This is a hypothetical example to explain cover questions, not a Mercantile client case or a paid claim. The proposed policy must be assessed before assuming any response.

Information needed for a quotation

Protocol and study stage; products or interventions; countries and sites; sponsor and CRO duties; participant numbers; ethics arrangements; compensation terms and existing policies.

Also provide turnover, wages, subcontractor and labour-hire costs, the legal entities to insure, existing schedules and wordings, claims or known circumstances, and planned changes. A clear activity breakdown helps us approach suitable markets and compare the terms offered.

Common questions

Does an Australian policy automatically cover US participants?

No. Written acceptance of the trial, territory and jurisdiction is essential, and any US site or local requirements must be separately assessed.

Can Mercantile review existing insurance?

Yes. Send the schedule and wording together with a description of your activities and key contracts. We can examine significant gaps and approach suitable insurers, subject to their appetite and acceptance. We assist Australian businesses from our Norwest NSW office.

Related insurance sectors

Our service focuses on insurance placement and policy cover. Product classification, approvals and regulatory compliance are matters for your regulatory adviser or the relevant authority.

Return to medical research insurance or explore all Life Science insurance sectors.

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• Life Science Research Consultant Insurance
• Medical Research Laboratory Insurance

Prepared by Mercantile Insurance Brokers. Updated 30 September 2026. General information for Australian businesses. Availability and cover depend on insurer acceptance, policy terms, exclusions, limits and deductibles.