Clinical Trials Insurance in Florida

Conducting a clinical trial is a trying and arduous task that requires strict adherence to federal and state laws, as well as precise record-keeping of the participants. You may be a research organization, a medical office, a biotech firm, a life science company, or a clinical trial sponsor. If you have a business in any of these categories, you may need to obtain clinical trials insurance in Florida.

What Is Clinical Trials Insurance?

Clinical trials insurance is coverage you have throughout the lifecycle of a clinical trial. Some insurance companies include this coverage with an existing policy, while others require you to purchase a separate policy.

According to the Department of Health and Human Services, its Federal Policy for the Protection of Human Subjects in a Clinical Trial defines a clinical trial as more than one human subject participating in a research study to determine the safety and effectiveness of a pharmaceutical drug or other intervention. These clinical trials do not have to study only FDA-approved drugs. They can also be used for drugs that have not been approved by the FDA yet.

Conducting clinical trials is often risky. Some of the risks include federal and state updates to regulatory compliance, participants having adverse reactions to your product, or medical lab equipment breaking down. Each of these problems can result in financial setbacks for your company.

What Does Clinical Trials Insurance Cover?

Clinical trials insurance coverage can protect you from general liabilities, meaning it can cover a wide range of anticipated losses, while other liability policies can be as specific as you would like them to be. Each medical organization and life science company has different goals while conducting a clinical trial. Having clinical trials insurance can help you reduce your overall expenses and safeguard your business interests.

Some of the elements you want to have coverage for include:

• The ethics committee and review board
• Your employees
• Professional liability
• Business income
• “Compassionate Use” coverage
• Financial compensation if a participant is injured
• A participant’s medical expenses
• Faulty lab equipment and medical devices
• A fleet of vehicles

These items fall under several kinds of coverage, including commercial property, general liability, commercial auto, and business income loss.

What Documents Do I Need to Obtain a Quote for Clinical Trial Insurance?

You will need three main documents to obtain a quote for clinical trial insurance. These key documents are:

• The Trial Protocol. A document that explains the protocols of the clinical trial in depth. This gives the insurance agent a “big picture” of your risks and what you need to protect for your business.
• The Informed Consent Form. This uses medical terminology that has been broken down into easy-to-understand words. They are written on an 8th-grade level so that most participants know exactly what to expect during the study.
• The Investigator’s Brochure. Most medical research companies have an Investigator’s Brochure. This document provides a thorough summary of the drug that is being studied.

Why Should You Hire a Life Science Insurance Lawyer in Florida?

There are several aspects to clinical trials and what qualifies as such. It is a complex process, and the FDA demands that it meet certain requirements. The clinical trial study must use an FDA-approved drug for cancer or an autoimmune disease. A clinical trial can also be for an interventional study. Furthermore, a study can include testing medical device prototypes for performance and efficiency.

In Florida, there are over 2,900 establishments operating in medical development, biotech, and pharmaceuticals. Life science insurance and clinical trial laws can be confusing for someone who isn’t familiar with legal jargon or these laws in general. When you hire a Florida life science insurance lawyer, they can interpret these laws and put them in layman’s terms for you to understand clearly. A lawyer can also help you review and choose the insurance plan that works for you.

Choose Our Firm

At Wilson, Washburn, & Forster Insurance, Inc., we have decades of combined experience navigating tricky insurance jargon and clinical trials insurance laws. Our team can use their experience and knowledge to guide you through the process of obtaining an insurance policy. We can examine your business needs and objectives and recommend appropriate coverage at affordable prices.

FAQs

Do Participants’ Health Insurance Cover Clinical Trials?

Yes, most health insurance companies cover participants’ medical costs in clinical trials. Health insurance usually covers imaging tests, such as X-rays, lab tests, and routine doctor visits. However, the company conducting the clinical trial usually pays for additional doctor appointments, lab tests for that particular clinical trial, the drug that is being studied, and x-rays or other imaging tests. These are not covered by the participants’ health insurance company.

How Much Does a $1,000,000 Liability Insurance Policy Cost?

The cost of a $1,000,000 liability policy varies. Insurance companies offer different types of coverage at competing rates. Additionally, if you want to protect different parts of your business, such as your employees or fleet of cars, you may want to have workers’ compensation insurance and commercial auto insurance.

You may also want to invest in a Master Policy or a Business Owner’s Policy (BOP), which protects against business income loss, as well as coverage for your commercial property and general liability coverage.

Does the Insurance Cost Increase if I Add More Participants After Receiving a Quote?

Many insurance companies calculate the quote per participant in the clinical trial and may charge a fee for additional participants. Thus, increasing your overall clinical trial insurance premium for that policy period, as well as when your policy renews. It is vital to contact your insurance company when these changes happen so you can anticipate the extra fees.

Can Clinical Trials Insurance Be Customized for a Specific Study in Florida?

Yes, clinical trials insurance can be customized for a specific study in Florida. Insurance policies can often be tailored to the trial’s duration, scope, risk profile, and participant population. Our risk and insurance consultant can help you determine appropriate coverage limits and meet all requirements while aligning with considerations specific to Florida.

How Wilson, Washburn, & Forster Insurance, Inc. Can Help With Your Clinical Trials Insurance in Florida

Finding reputable and reliable insurance for clinical trials can be a difficult task, but we can help. We provide exceptional service and can help your company mitigate risk with the proper clinical trials insurance coverage. Schedule a consultation today to speak to a Florida life science insurance attorney. We’re looking forward to giving you peace of mind for your business.