Clinical Research & CRO Insurance
Before choosing a policy structure, define who sponsors, manages, treats, monitors, analyses and holds data. The insured's role in each study determines the exposure, not the industry label.
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Hard-to-place
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Australia
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The Tank take
Clinical research businesses may need professional indemnity, clinical trials liability, medical professional liability, public liability and cyber - but not every consultant needs every section. The insured's role in each study determines the exposure.
A consultant who provides operational advice without sponsoring trials, treating patients, attending sites or signing regulatory documents looks very different to an underwriter than a CRO or sponsor that accepts participant, ethics and monitoring responsibilities. Getting that distinction on paper is most of the placement.
Start with who does what in the trial
Clinical research insurance begins with a party map: sponsor, CRO and site each carry different exposures, and one business can hold more than one role.
Initiates and owns the trial
Owns the protocol, regulatory pathway and compensation framework. Delegating tasks to a CRO does not automatically remove sponsor obligations, which is why sponsor-side clinical trials liability is its own placement question.
Performs delegated services
Monitoring, data management, pharmacovigilance, project management and site services create professional and contractual exposure. A CRO's core cover is usually PI shaped around exactly which duties are delegated in writing.
Delivers the protocol to participants
Recruitment, consent, treatment and clinical judgement can create medical liability that neither the sponsor's nor the CRO's policy is designed to pick up. Site and investigator cover has to be checked in its own right.
Consulting into trials is not running trials
A clinical operations consultant who advises sponsors and CROs on programme management works inside the trial ecosystem without holding trial responsibilities. That distinction changed a real placement: Tank placed PI and $10M general liability with US cover for exactly this kind of consultancy at around $1,500 including fees, because the submission proved the business did not sponsor trials, treat patients or manufacture products.
The negative statements that support this classification are specific: no studies conducted, no sponsor role, no ethics responsibility, no patient contact, no site attendance beyond declared visits, no regulatory sign-off. Where any of those do apply, the structure changes - honestly and deliberately.
See the full breakdown in our consultant case studies and the CRO vs sponsor vs site responsibility map.
Complex science deserves a precise submission
Tell us what you advise on, build, test, supply or operate. We take the risk to insurers with genuine life sciences appetite and explain the terms before you decide.
The sections to test against each role
Commonly needed
- Professional indemnity for consulting, research management, data and regulatory services
- Public liability for site attendance and premises exposures
- Cyber for participant data, research platforms and vendors
Role-dependent
- Clinical trials liability - usually sponsor-side, for participant injury and compensation obligations
- Medical professional liability - where clinicians diagnose, treat or exercise patient-specific judgement
- Property and research-asset cover for laboratories and samples
Titles do not decide responsibility; trial documents and contracts do. The policy structure should follow the delegation log, not the org chart.
What insurers ask clinical research businesses
- 01
Is the insured a sponsor, CRO, site, investigator, consultant or more than one?
- 02
Which tasks are delegated in writing, and which responsibilities remain?
- 03
Are patients recruited, consented, treated or monitored by the insured?
- 04
What phases, indications, participant numbers and countries are involved?
- 05
What indemnities, compensation arrangements and insurance requirements apply?
- 06
How are safety events, data quality, privacy and subcontractors controlled?
How we structure a clinical research placement
Map the roles
We identify your role in each study from the trial documents and contracts, not the job titles.
Match the sections
PI, trials, medical, public liability and cyber are included or excluded deliberately, with the reasoning documented.
Prove the boundaries
Negative statements and delegation evidence let underwriters classify the risk accurately, which is what earns competitive terms.
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
Explore cover by business activity
Questions about Clinical Research & Trials
No. A purely operational or advisory consultant may principally need PI. Trials, medical and other sections depend on the actual responsibilities held in each study.
A CRO performs delegated research services; the sponsor initiates and oversees the trial framework. Contracts allocate tasks, but delegation does not automatically transfer sponsor responsibilities.
No. Under the CTN pathway the TGA does not evaluate trial data before notification. Ethics review, institutional authorisation and sponsor oversight remain central to trial governance and to underwriting.
Research businesses often hold sensitive participant data and depend on digital platforms, vendors and cross-border data flows. A breach can combine privacy liability with trial disruption.
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.
Put your life sciences risk in front of the right markets
Tell us what you research, build, test, supply or operate, plus any overseas exposure. We will explain the available terms and exclusions before you decide.