Clinical Trial Insurance Additional Considerations

Who Needs Clinical Trials Coverage?

If your organization is involved in clinical trials there is a good chance that you need clinical trial insurance coverage for your clinical trial liability. Medical device manufacturers and drug development companies that sponsor clinical trials are usually required to hold some sort of clinical trial coverage for the product or drug. This coverage protects against bodily injury and property damage that is a result of the product that is being tested.

Underwriting Considerations for your Clinical Trial Insurance

When you are going through the underwriting process for your clinical trial insurance coverage it is important to understand what the insurance carrier is looking at. The first priority to placing your coverage is to work with an experienced agent or broker who knows how to handle clinical trial insurance and has the insurance carriers needed for the coverage.

Once you start the underwriting process there are many things that will be taken into consideration for your coverage and pricing. First of all the underwriter will look at what phase and how many subjects are involved in the study. Next they will review the study protocols and your sample informed consent form. Other considerations include; the reputation of your clinical research organization, how successful previous studies were in recruiting subjects and performing the study, and your company reputation and stability.

As the litigious environment surrounding clinical trials continues to increase, the costs associated with your clinical trial insurance also continue to increase. Be prepared to pay between $10,000 and $30,000 per year for your trial for the insurance that you need. If you are involved in more then one trial it is possible to include them all in one yearly policy, which reduces the administrative burden and usually costs associated with insurance.

Choosing the right carrier for your Clinical Trial Insurance

Once you are through the underwriting process it is now time to review your insurance options. Although price is usually an important consideration, do not let it be the only one. Clinical trial insurance is a very specialized type of insurance and one that needs expertise. Be sure to choose a carrier that is experienced in clinical trials and has a solid financial rating to assure stability. In addition consider whether the carrier is admitted or non-admitted. If the carrier is non-admitted they are not regulated by the state insurance commissioner and do not have access to the guarantee fund in case of insolvency.

Another important item to consider is the cost of the extended reporting period. This is a coverage that provides additional time for claims to be reported and needs to be negotiated before the policy is purchased. Another important consideration is whether the policy is claims made or claims made and reported. For a claims made policy it requires you to report the claim during the same policy period as the claim was made against you. It limits the time for you to report the claim, whereas a true claims made policy usually requires that the claim be reported ‘as soon as practicable’.

Some final considerations are that it is usually best to keep your clinical trial insurance coverage with the same carrier as your products coverage for your normal insurance. This is important; because if there is a claim it is clear which carrier is responsible for defense and coverage. Finally, if you are considering international studies or products coverage, it is important to have a broker and carrier who can handle the international landscape for your insurance needs.

Contact Ahmann-Martin: To build an insurance policy that will be effective and affordable, you need a company that customizes your policy for you. Visit us at Small Business General Liability Insurance to consult with an insurance professional who will construct a clinical trial insurance policy that will work for you.

Return to Blog Home

Seth Stores, CIC, is an experienced insurance professional, working with Ahmann-Martin in suburban Minneapolis. His practice is focused on providing affordable insurance alternatives for life science companies. You may call Seth today, at (800) 600-6185, or fill out our simple Contact Us form to the right and we will return your call during business hours.