Because clinical trials are conducted on human volunteers, rigorous controls and procedures must be in place to ensure the wellbeing of the participants - often including clinical trials insurance. The developer or “sponsor” may conduct the clinical trial themselves or engage a Clinical Investigator or CRO (Contract Research Organisation) to do it for them. The insurance is usually a regulatory or contractual requirement.
Unforeseen risks are inherent in medical research. Specialist clinical trials insurance is a vital piece of the jigsaw and is designed to provide financial protection for those conducting clinical trials and to provide compensation for the trial participants in the event they suffer harm.
How can I get a quote for my organisation's clinical trial insurance?
Insurers will require the following information in order to quote:
The Protocol Document, which acts as the trial plan and includes details such as:
The indemnity limit required for liability insurance - often set by the ethics committee (also known as “institutional review boards” in the USA).
Details of the investigator or CRO who will conduct the trial.
Remember that the ethics committee or review board will often require proof of insurance before allowing a trial to start. If trials are being conducted overseas, it’s often necessary to produce insurance certificates in the local language. Failure to arrange the insurance in time often results in costly delays.
How does clinical trial insurance work?
Clinical Trial Liability Insurance is available from specialist insurers. The policy provides protection in two ways:
How can I manage my risk exposure in relation to clinical trials?
Insurance is only part of the solution. You can take positive steps towards protecting yourself from liability by keeping a close eye on:
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