Clinical Trials

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If your company is involved in medical research programmes, clinical trials insurance is an essential part of your risk management package. It’s designed to provide protection for your participants as well as your business should something go wrong. Clinical trials insurance is not offered by all brokers or providers - it’s specialist cover and needs specialist insurance advice.

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.

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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

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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.

Vaccine trials

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.

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Meet the team

Hanna Beaumont

Partners: Science & Technology

Paul Monaco

Client Director

Bernice Morris

Client Executive
Elaine lamb

Elaine Lamb

Client Director

Hanna Beaumont

Partners: Science & Technology
A fellow of the Institute of Risk Management, Hanna is a specialist in life science insurance, including clinical trials liability. From start-up to IPO and international expansion, she supports clients with advice and specialist insurance programmes to build resilience into their business planning and operations. Working across bioscience, CROs, health tech and pharmaceuticals, Hanna invests significant time working with early-stage enterprises to keep them robust and sustainable through the pressures of high growth.

Paul Monaco

Client Director
Paul has almost 30 years in the insurance industry, 22 years of which has been as an insurance adviser, specialising in providing clients with specialist advice particularly in life science and health tech.

Bernice Morris

Client Executive
With 30 years’ experience in insurance, Bernice works with science and tech businesses, developing tailored insurance solutions for start-ups seeking investment to large corporates requiring a global solution. Her clients love her professional approach and quick problem-solving.

Elaine Lamb

Client Director
Elaine Lamb specialises in arranging seamless insurance portfolios for transatlantic life science and health tech businesses.