Clinical trials risks
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.
The need for clinical trials insurance
The ethics committee or review board will often require proof of insurance before allowing a trial to start – and failure to arrange the insurance in time can result in costly delays.
Clinical Research Organisations (CRO)
If you outsource the management of your clinical trials to a CRO, it’s important that the CRO themselves has protection against claims arising from the services they provide if something were to go wrong.
How does clinical trials liability insurance work?
Human clinical trials are subject to rigorous controls and procedures 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.
What if your trial results in participants being harmed and potentially requiring life-long medical care?
This could lead to the participate (or their dependents) demanding compensation or rejecting the compensation guidelines and suing you independently for greater damages.
Who we support
Drug discovery & development
The development of new drugs is vital work and is often a long and difficult process. Part of this will involve clinical trials involving human participants. Clinical trials insurance is essential to protect all parties involved.
Contract Research Organisations (CROs)
CROs provide services to the life science sector – particularly pharmaceuticals and biotechnology companies. As such, CROs are exposed to a wide range of liabilities including clinical trials and medical malpractice risks.
Medical device companies
Medical devices exist in many forms – an instrument, machine, implant, appliance as well as software, medtech and healthtech apps that are developed for medical purposes. All are subject to rigorous testing and clinical trials before they can be launched into production.
Covid-19 brought the production of new vaccines to the forefront. Clinical trials were a vital part of this process and are central to the production of any new vaccines. We’re able to support organisations involved in the discovery and manufacture of new vaccines with clinical trials insurance solutions.
Usual types of cover
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. Whether you’re researching new drugs, processes or medical devices, having the right clinical trials insurance solution is crucial.
Clinical trials liability insurance provides protection in two ways:
resulting from negligence, lack of due diligence or care on the part of the sponsor, investigator or CRO. The policy pays for legal costs and expenses with compensation or “damages” awarded;
harm with no specifically identified cause, but likely to have arisen from the participant taking part in the research. Participants may sometimes suffer non-negligent harm and expect compensation even in the absence of 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.
NB: If trials are being conducted overseas, it’s often necessary to produce insurance certificates in the local language.