CRO vs Sponsor vs Site
Contracts allocate tasks, but the insurance programme must reflect every party's real work and retained responsibilities. Gaps emerge when two parties each assume the other's policy responds.
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The Tank take
The sponsor, CRO and clinical site perform different functions and should not be treated as interchangeable insureds. A sponsor initiates the trial framework, a CRO performs delegated services, and a site or investigator interacts with participants - and each needs its exposure insured in its own right.
Delegating monitoring, pharmacovigilance or data work does not necessarily remove the sponsor's obligations, and the CRO's policy does not automatically insure the sponsor or site. The gaps live in the assumptions between the parties.
Who carries what
Framework, oversight, compensation
Protocol ownership, regulatory pathway, safety oversight and participant compensation arrangements can all sit with the sponsor - including tasks it thinks it delegated. Sponsor-side clinical trials liability responds to participant injury and defined compensation obligations.
Delegated professional services
Monitoring, data management, safety reporting and operational services create professional and contractual exposure. The delegation log defines the insurable scope, and the CRO's PI should match it precisely.
Participant care and protocol delivery
Consent, clinical care, protocol delivery and clinical judgement can create medical liability. Whether the site is an additional insured under the sponsor's programme, separately insured, or both, has to be established rather than assumed.
The assumptions that create uninsured space
The sponsor believes the CRO's policy covers a monitoring failure; the CRO believes the sponsor's trials policy covers the participant. Both can be wrong at the same time. Named insureds and indemnities need to be read, not assumed.
Clinical negligence by an investigator may need medical professional or institutional cover. The sponsor's trials wording cannot be assumed to replace it.
Laboratories, data vendors, couriers and technology providers can cause critical trial failures while sitting outside every trial party's policy. Contract insurance requirements are the control.
If the delegation log and contracts do not evidence who holds a duty, underwriters price the ambiguity - or exclude it. Written scope protects both the placement and the claim.
The questions that close the gaps
- 01
Which party is named as sponsor in the trial documents?
- 02
Which duties are delegated to the CRO and evidenced in writing?
- 03
Who obtains consent and provides clinical care?
- 04
Which policy responds to participant injury and compensation obligations?
- 05
Are sites, investigators or vendors additional insureds or separately insured?
- 06
What cross-indemnities, liability caps and governing laws apply?
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.
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Questions about CRO vs Sponsor vs Site
Not automatically. Delegation can transfer tasks while sponsor responsibilities and the named sponsor status remain. The trial documents control.
It cannot be assumed. Named insureds, additional insured provisions, indemnities and separate site insurance must be checked for each trial.
Medical professional or institutional insurance may be relevant. The sponsor or trials wording cannot be assumed to replace it, and the gap between them is a common finding in contract reviews.
Laboratories, data vendors, couriers and technology providers can create critical failures while sitting outside the named insureds' policies. Contractual insurance requirements and recourse are the practical control.
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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