Arguably the most important part of the research and development journey for any business is the clinical trials stage – which is why clinical trials insurance is crucial.
Even the best-planned clinical trials can carry a level of risk. Dedicated clinical trial insurance ensures you and your company are covered for trials both large and small, so if the unexpected happens, you’re protected.
Why Clinical Trial Insurance Matters
Securing insurance for clinical trials ensures that, no matter the outcome, your company is protected if anything should go wrong. Plus, human trials cannot proceed until you have the correct insurance in place, clinical trials liability insurance is a necessary step to having your trial agreed by ethics boards.
When looking for a clinical trial insurance quote, make sure you have the following information to hand:
- The number of participants
- The length of the trial or study
- The indemnity limit
- The protocol of the trial itself
Our team will be able to put together a bespoke quote for your requirements and walk you through it so you understand exactly how you’re covered.
What Does Clinical Trial Insurance Cover?
The sensitive nature of clinical trials means that your insurance has to be approached with care and sensitivity for a successful policy. Through our partner insurers, we can arrange coverage for events such as:
- Feasibility studies and all phases of clinical trials.
- Negligent harm.
- No fault compensation.
- Multiple trial sites across various geographical locations (local laws considered).
- Long tail extended reporting periods.
- Insurance cover (paper) written to various territories, local laws, and languages and considering varying international ethics committees.
- Non-fault liability for bodily injury to a research volunteer.
- Damage to a volunteer’s property during clinical trials.
We can add on additional insurance requirements depending on your needs, such as if you’re carrying out international trials.
Our underwriters keep pace with our client requirements, and it is not unusual for a trial sponsor to make last minute changes to their coverage. Often, insurance documentation is required to reflect changes that a sponsor might make to ICF or Protocol documentation.
Who Needs Clinical Trial Insurance?
We provide insurance for clinical trials for a range of businesses, including:
- Biotechnology companies
- Hospitals
- Medical device companies
- Contract Research Organisations (CROs)
- Universities
- Research institutes
If you’re curious if your company could benefit from clinical trials insurance, book a consultation with us today. We’ll assess your needs and identify the ideal insurance for you.
Why Choose All Med Pro For Clinical Trial Insurance?
Since 2011, we have been dedicated partners to the life science industry. Since our inception, we’ve been working to do things differently, offering unique insurance features and schemes that bring real benefit to you.
Our clinical trial insurance is bespoke to you, covering your unique requirements and
Book a consultation with us today to discover more.
Simon Wyndow heads up our Life Sciences team. In 2009 Simon began his insurance career in general commercial insurance advising and broking. Over the years of general practice, Simon took a professional and personal interest in medicine and biochemistry. Building upon this interest, he has developed experience and understanding of varying life sciences businesses and their complex risk management requirements.
All Med Pro works in partnership with specialist UK and Global insurers.
Clinical Trials Insurance FAQs
What Is Clinical Trial Insurance?
Also known as clinical trials liability insurance, this policy ensures your company is covered for any accidental damages or injury that occurs during a clinical trial. It is a legal requirement if you are carrying out a trial in the UK.
Is Clinical Trial Insurance A Legal Requirement?
Yes, in many cases, clinical trial insurance is a legal requirement. In the UK and across the EU, regulations such as the Medicines for Human Use (Clinical Trials) Regulations 2004 and the EU Clinical Trials Regulation (EU CTR) mandate that appropriate insurance or indemnity is in place before a trial involving human participants can commence. This is to ensure that participants are protected and can receive compensation in the event of injury or harm related to the trial.
How Much Does Clinical Trial Insurance Cost?
The cost of clinical trial insurance varies significantly depending on several factors, including the nature and phase of the trial, the number of participants, the countries in which the trial is being conducted, and the level of risk involved.
Get in touch with All Med Pro today for a bespoke quote based on your exact requirements.
What Is The Purpose Of Clinical Trial Insurance?
The purpose of clinical trial insurance is to protect both the participants and the sponsoring organisation. It provides financial coverage in the event that a participant suffers harm as a result of their involvement in the trial.
Clinical trial insurance ensures that claims for compensation can be met, thereby supporting ethical conduct, regulatory compliance, and participant confidence in the research process.
