Clinical Trials Insurance
Participant protection, sponsor responsibilities and legal liability aligned with the protocol, countries, sites and indemnity framework - arranged before the trial starts, not after.
Specialist
Market access
Hard-to-place
Our focus
Australia
National broking
Recognition
The Tank take
Clinical trials insurance can address defined participant injury, legal liability and, where offered, no-fault compensation obligations. It is specialist cover that must be aligned with the sponsor, protocol, phase, participants, countries, sites and indemnity framework.
A CTN acknowledgement is not a TGA evaluation of the trial. Ethics review, institutional authorisation, informed consent, safety monitoring and sponsor oversight remain central to trial governance, and they are exactly what underwriters ask to see.
What moves trial risk for an underwriter
Trial severity depends on the intervention, participants and protocol; coverage depends on the exact legal and compensation obligations accepted.
First-in-human, invasive, vulnerable-population and higher-risk interventions can materially narrow appetite. The protocol is the primary underwriting document.
Numbers, ages, territories and local compensation frameworks shape both limits and structure. Multinational trials may need local policies alongside the Australian programme.
Participant information, adverse-event escalation and safety governance are core underwriting evidence. A trial that can show its safety machinery presents as a controlled risk.
Sponsor, institution, site and investigator agreements determine who has promised to respond to what. The Medicines Australia indemnity framework is the common Australian reference point.
What a trials policy addresses, and what it does not
Can be within a trials wording
- Participant injury arising from the declared trial
- Legal defence for trial-related claims
- No-fault compensation obligations where offered and scheduled
- Defined trial activities listed in the schedule
Usually needs separate cover
- Ordinary medical negligence by investigators or clinicians
- The sponsor's general professional or product exposures
- Trials, sites or countries not declared in the schedule
- Material protocol changes made after binding without notification
Trials sections are commonly claims-made and tied to precisely scheduled activities. Material changes to protocol, sites or countries should be notified before they happen.
What to have ready before approaching the market
- 01
The protocol, phase, indication and intervention
- 02
Participant numbers, sites and countries
- 03
Ethics, regulatory and institutional approvals or notifications
- 04
Consent, adverse-event and safety monitoring procedures
- 05
The indemnity and compensation guidelines adopted
- 06
Prior trials, claims, incidents and material protocol changes
Check the current Australian guidance
Regulatory obligations sit outside your insurance policy. These official sources are the starting point.
External government and industry sources. Tank Insurance is not responsible for their content; confirm current requirements with the relevant body.
Related life sciences guides
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Questions about Clinical Trials Insurance
Depending on the wording, it can address participant injury, legal defence and compensation obligations associated with a declared trial. Sections, triggers and exclusions vary, and the schedule controls which activities are insured.
Before the trial begins and early enough to meet ethics, institution, contract and regulatory requirements. Material changes should be notified as the trial evolves.
Sometimes, but each country, local requirement, entity, site and jurisdiction must be reviewed. Local policies may be required in some territories.
Not necessarily. Investigator or clinical negligence may require separate medical professional or institutional cover alongside the trials programme.
General information only. This page does not take account of your objectives, financial situation or needs and is not legal advice. Cover depends on the insurer, policy wording, limits, excesses, exclusions and information disclosed. Read the relevant policy documents and obtain professional advice before deciding.
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