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Because clinical trials are conducted on human volunteers, strict controls and processes must be in place to ensure the wellbeing of the participants – including clinical trials insurance. The insurance is usually a regulatory or contractual requirement.
If your company is involved in medical research programmes, clinical trials insurance is an essential component of your risk management package. This will provide protection for your participants as well as your business should something go wrong.
Negligent harm to trial subjects
Caused as a result of negligence, lack of due diligence/care on the part of the sponsor, investigator or CRO. The policy pays for legal costs & expenses and compensation or “damages” awarded to the subject.
Non-negligent harm (or “no-fault” compensation)
Harm with no specifically identified cause, but likely to have arisen from the subject taking part in the research. Subjects in clinical trials will inevitably sometimes suffer non-negligent harm, with the expectation of being compensated despite there having been no negligence on the part of the sponsor or CRO.
The policy pays compensation in accordance guidelines set out by competent authorities, such as the Association of British Pharmaceutical Industries or the equivalent in the country where the trial is taking place.
Whether you’re running mass clinical trials, smaller studies, or just beginning your recruitment, you’ll know that clinical trials can come with significant negligence, malpractice and liability risks.
To get your clinical trial approved by an ethics committee, you will need a clinical trials liability certificate of insurance specific to the territory in which the trial will take place.
The ethics committee or review board will often require proof of insurance before allowing a trial to start. Failure to arrange the insurance in time often results in costly delays or not having the permission granted to conduct the trial.
Clinical Trials Insurance covers bodily injury (subject to policy terms/conditions) to a research subject due to their participation in a clinical trial, as set out in the protocol document. Research subjects are covered for all stages of the trial, i.e. screening, treatment and follow-up as soon as the consent form is signed.
If you are looking for a quote for Clinical Trials Insurance then talk to our team of experts. We will gather all the necessary information to find the best solution for your cover requirements. The information we will need includes:
Given the nature of a clinical trial, it’s imperative that insurance cover has been approached correctly to avoid issues in the event of a claim. As well as the information above which is needed to provide a quotation for Clinical Trials Insurance, it’s important to also taking account the following factors:
The depth of detail required in order to take out a clinical trials policy can vary, and we will take the time to ensure that all necessary information is gained and understood before sourcing a solution for your insurance needs. It’s essential that the information provided is comprehensive and accurate as failure to provide the correct details can lead to the policy being void and a claim being refused.
Clinical Trials Insurance is a necessity prior to the inception of the study. As such, it’s essential to begin exploring insurance options early on in the process to ensure the right cover is provided and in the required time frame. Given the nature of clinical trials, often third parties such as sponsors and investors, will require proof of insurance cover. Failing to do so in good time or having the right cover in place can create delays to the trials process.
Clinical Trials Insurance is not offered by all brokers or providers or brokers. It’s specialist cover and therefore it’s essential to engage the services of a company that has expertise in Clinical Trials Insurance. The team at FOCUS are experts in life science and Clinical Trials Insurance and are one of only a handful of brokers that have long-standing relationships with specialist providers. This allows us to arrange Clinical Trials Insurance to provide the cover you need to meet your specific requirements.
Clinical Trials Insurance can provide cover in two different ways.
Firstly, insurance can be provided for negligent harm to trial subjects. This provides cover for compensation, legal costs and expenses in certain cases. This type of cover is applicable if the nature of the claim can be directly tied to the clinical trial as a result of negligence, lack of due diligence/care on the part of the sponsor, investigator or CRO.
Non-negligent harm, or “no-fault” compensation, is a further level of protection available when facing a claim from a trial participant. When harm has been caused, but that which cannot be directly tied and is only likely to have been caused by participation, no-fault compensation will be best placed to provide protection.
Yes, a bespoke policy can be arranged to accommodate freezer failure and the deterioration of the contents. However, insurers may well require confirmation that the freezers in question are fitted with an alarm – particularly if the contents are of very high value.
Insurers will require the following information in order to quote:
With this information FOCUS can provide you with the a solution to suit your needs.