Clinical Liability Trial Insurance
Why do clinical trial sites require insurance and/or an indemnity
Clinical Trials insurance provides protection for those who sponsor and conduct clinical trials, arising from claims made against them by the trial participants. Cover can be provided on a No Fault Compensation basis to meet Australian Guidelines, including that of the Human Research Ethics Committee.
In additional the above, a legal liability extension can be added, as well as a medical malpractice extension if the trials medical practitioners own defence cover excludes trial work.
Cover can also be provided for
- pre-clinical research;
- bioequivalence testing;
- medical devices; and
- all Phases of drug trial from Phases I to IV.
Organisations that conduct clinical trials are often exposed to risks such as condemnation of undamaged stock, property at unspecified locations, spoilage, contamination, crisis response, product recall and regulatory inquiries. Covers are available to develop bespoke policies for these risks.
We have clients based both nationally and worldwide and we can arrange cover either on a per protocol or on an annual declaration basis.
McKenzie Ross can structure a robust, single policy solution that encompasses the multi-facets of exposure, including:
- Errors and omissions insurance for consequential damages arising from negligent performance or non-performance of any aspect of a trial. Policies generally can cover the costs of repeating a portion or a whole phase of a clinical trial.
- Medical malpractice coverage for bodily injury claims by subjects arising from medical services or during the course of medical services.
- Products liability insurance for liability arising out of the handling, distribution, or manufacturing of drugs/medical devices during the pre-clinical and clinical phases, in Phase IV post-marketing surveillance, and thereafter.
- Clinical trial medical expense coverage, sub-limited to respond to out-of-pocket medical expenses required of trial participants. This coverage can support the insured’s timely response to acute medical needs arising from products administered or services rendered during the trial
- General liability for premises-related bodily injury/personal injury, property damage and advertising liability claims.
Why do clinical trial sites require insurance and/or an indemnity?
Indemnity and insurance arrangements are taken out to protect the clinical trial site against liabilities that it may incur in the course of its clinical trial activities. In the case of insurance, the insured will typically be the institution, its directors and employees (including researchers).
Although clinical trial participants are neither indemnified or insured parties, insurance and indemnity arrangements ensure that an institution or sponsor is able to compensate participants who are harmed in a trial. For this reason, evidence of appropriate insurance and indemnity arrangements must be provided as part of documentation submitted for ethics review.
If cover is provided by way of an indemnity or managed fund or scheme arrangement, the relevant State or Territory underwrites the risks, however, unlike insurance arrangements, the cover provided under an indemnity or managed fund arrangement may be discretionary leaving your trial exposed to severe losses
Clinical trial researchers who are employees of the relevant private sector entity may be covered under the entity’s clinical trials insurance arrangements. However, many clinicians conducting clinical trials in a private sector entity will not be employees of that entity. Researchers that are not employees are required to have in place professional indemnity or medical indemnity insurance that includes coverage for clinical trials as a condition to participate in the conduct of a clinical trial.
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As an experienced clinical liability trials insurance broker, our relationships with specialist local clinical trials underwriting agencies ensure we are able to offer a suitable solution for this unique risk.