Clinical Trials Insurance

Get your clinical trial past the ethics committee

Clinical Trials Insurance

Your clinical trial has stalled. You need insurance to get your clinical trial through the ethics committee but you’re struggling to find an insurer. Without clinical trial liability insurance (or a quote) your trial won’t get approval. And time is running out. We know how and where to get an approval-worthy quote in record time. So your trial can go ahead.

What is Clinical Trial Liability Insurance?

Clinical trials establish whether a medical treatment, device or strategy is effective and safe for use on humans. And Clinical Trials Insurance provides the financial protection for the sponsor (or research organisation) and the volunteers in case anything goes wrong.

The Medicines for Human Use (Clinical Trials) Regulations 2004 (and subsequent amendments) state that a clinical trial can only go ahead if “insurance or indemnity” is in place to cover the liability of the researchers. Which means your ethics committee or approval body will insist on Clinical Trial Insurance cover before they approve your trial.

“Clinical trials insurance isn’t complicated but lots of insurers shy away from it. We know exactly which insurance markets to approach and we chase quotes relentlessly. We can even negotiate a flexible start date if your trial doesn’t start straight away.”

– Tony Gibbs, Clinical Trials Insurance Specialist

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Talk to Tony about approval-worthy Clinical Trial Insurance:

How Clinical Trial Insurance protects you

Clinical trial claims are generally infrequent. But when things do go wrong, the impact to human health can be devastating. So your insurance offers protection in two ways:

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  • Negligent Harm

    Cover for legal costs, medical expenses and compensation awarded to trial participants as a result of negligence or lack of due diligence.

  • Non-Negligent Harm (no-fault)

    Compensation in line with the ABPI guidelines (Association of the British Pharmaceutical Industry) to participants who have suffered harm where there is a ‘causal but no-fault link’ between the study and an injury.

Top tips for Life Science Insurance cover

  • Research scientists are unlikely to think about insurance, so getting cover in place early prevents panic as development advances and a trial becomes real.

  • When you’re under pressure to get an insurance quote quickly, here’s the information you’ll need: 

    • The protocol (or draft protocol) 
    • Indemnity limit
    • Consent document 
    • The length of the trial
    • The number of participants (normally included in the protocol)

  • ‘First in human’ trials along with trials involving pregnancy and children are riskier so you may be asked for more detailed information.

A human clinical trial can’t start until the correct insurance cover is in place.

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