Clinical Trial and Research Insurance

In today’s environment it is increasingly difficult for companies to keep pace with changing clinical trials regulations and enforcement in every corner of the world. Ethics Committees will often require proof of local insurances and may insist on specific wordings and limits being incorporated into your policy document. As a specialist in clinical trials insurance, JLT provides a complete solution for companies needing this insurance cover.

Before a clinical trial can begin, it needs to be reviewed and authorised by a government agency called the Medicines and Healthcare products Regulatory Agency (MHRA). Furthermore, all medical research involving people in the UK has to be approved by an independent research ethics committee which protects the rights and interests of the people who take part in clinical trials.

The EU directive for clinical trials – Directive 2001/20/EC – stipulates that sufficient funding has to be available to provide indemnity if there is any bodily injury to research subjects taking part in a trial, and insurance provides this confirmation of indemnity. In fact, it is highly unlikely that the ethics committee will approve a clinical trial that has inadequate or no insurance in place.

As a specialist clinical trials broker, JLT provides a complete solution for life science companies needing this insurance cover.

WHAT WE DO

We manage insurance for thousands of clinical trials from large global programmes to single territory trials.

WE PROVIDE:

  • Quotations and placement of compliant and competitively priced clinical trials insurance cover
  • A full-service insurance resource for providing central co-ordination between you and your insurers
  • Stand-alone consultancy advice on clinical trials insurance cover and requirements
  • Clinical trials insurance claims management.

Our clients range from major pharmaceutical organisations to start-up companies. Whether it is for a single or multiple territory trial, we offer our services with the same standard and quality worldwide.

We recognise that arranging clinical trials insurance can be an administrative burden so we have developed a streamlined certification process.

This ensures a fast response and minimises the administration costs for our clients.

FAQs

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.

Each clinical research is unique and we will be unable to confirm the cost for your clinical trial insurance without obtaining certain details from you. Please contact JLT's team and we will use our extensive market relationships to provide you with the most competitive quotes.

Insurers normally ask for a copy of the draft study protocol document (the document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial) and informed consent form (the form in which a participant confirms his or her voluntary consent to participate in a trial) to be able to provide a quote. You can obtain a quote for your clinical trials insurance by contacting one of our clinical trials specialists.

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 they sign the informed consent form.

We at JLT use our extensive and up-to-date knowledge of regulatory changes from territories across the globe to ensure that your policy is compliant in any territory where you wish to conduct clinical trials.

WHY JLT

COMPETITIVE PRICING
Our extensive experience of working with specialist clinical trials insurers enables us to secure competitive terms for our clients. We can quickly benchmark insurer’s pricing to ensure that their terms are attractive and can provide you with guidance on insurers’ capabilities in the countries where you are undertaking trials.

TAILORED ADVICE
We maintain a detailed database of global clinical trials insurance legislative requirements and we track regulatory changes that affects the necessary territorial coverage. This knowledge enables us to provide you with up-to-date advice and helps to ensure that the insurance you purchase is compliant.

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