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Clinical Trials Insurance in Massachusetts

Clinical trials insurance policies are highly specialized commercial insurance policies for institutions that conduct clinical trials. Because these are such specialized policies and the potential risk posed by trials is so significant, organizations should work closely with an insurance agent who focuses on this unique type of insurance when searching for coverage.

Pharmaceutical drug makers
Medical device makers
Medical research facilities
Medical schools that conduct trials

Non-negligent harm that participants sustain
Negligent harm that participants sustain

What is Clinical Trials Insurance?

Clinical trials are essential to many scientific and medical advancements, and treatment would be nowhere near what it is today without this essential scientific approach. Even when done with the utmost care and caution, however, trials present significant liability risk. Clinical trials insurance policies help Massachusetts laboratories protect themselves from many of the liability risks that come with conducting these types of trials.

Clinical trials insurance policies are highly specialized commercial insurance policies for institutions that conduct clinical trials. Because these are such specialized policies and the potential risk posed by trials is so significant, organizations should work closely with an insurance agent who focuses on this unique type of insurance when searching for coverage. A knowledgeable agent will be able to help organizations assess their risk exposure and find the most suitable insurance that’s available.

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What Massachusetts Organizations is Clinical Research Insurance Right For?

In general, the vast majority of organizations that conduct clinical trials in Massachusetts should have clinical research insurance in place. Many will be required to carry the insurance before beginning trials (and throughout the duration of their trials).

The following are some examples of different organizations that might need this insurance:

  • Pharmaceutical drug makers
  • Medical device makers
  • Medical research facilities
  • Medical schools that conduct trials

(This isn’t intended to be a comprehensive list, and many other organizations may need a clinical research policy.)

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Are All Clinical Trials Covered by Clinical Trials Policies?

Just as is true with most types of insurance policies, the particulars of what a clinical trials policy will cover are normally detailed in that policy’s paperwork. Many policies will cover certain classes of trials provided that they meet all regulatory requirements and have all the necessary paperwork appropriately filed. Of course, regulatory requirements might include both federal requirements and local requirements -- the latter of which can vary.

An insurance agent who’s familiar with these types of policies can help organizations find a policy that meets their needs. With the assistance of an informed agent, organizations can determine their exact coverage requirements and find policies that meet those requirements.

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What Coverages Are Available Through Clinical Research Insurance?

In most cases, clinical research insurance provides protection against two types of harm that can occur during trials:

  • Non-negligent harm that participants sustain
  • Negligent harm that participants sustain

Non-negligent harm may also be called “no-fault compensation.”

With both of these protections, it’s important to notice that the protection offered is normally limited to only trial participants. Since these policies usually are specialized to protect against trail-related risks, participants are typically the only ones who fall within the policies’ protections.

Clinical Trails Insurance Massachusetts

Does General Liability Insurance Cover Clinical Trials?

Organizations that run clinical trials typically also need general liability insurance but not necessarily to protect against risks that are specifically trial-related. General liability tends to exclude the liabilities that come with clinical trials. Instead, it may protect against more common risks like slip-and-fall accidents and the injuries those accidents can result in. 

Thus, general liability and clinical research insurance normally offer distinct protections and are often both purchased by medical organizations.

Clinical Trails Insurance Massachusetts

How Can Massachusetts Organizations Get Clinical Trials Insurance?

If your organization needs insurance for clinical trials that will take place in Massachusetts, contact the insurance agents at Scotti Insurance Agency. Our independent agents can show you clinical trials insurance options from many insurers in the state, and we have the expertise necessary to help you decide which of the available options is the best policy for your organization. With our help, you can be confident that your organization is well-protected from the risks that its clinical trials create.

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Winchester, MA 01890
Call: (781) 729-9200
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This material is for informational purposes only. All statements herein are subject to the provisions, exclusions and conditions of the applicable policy, state and federal laws. For an actual description of coverage, terms and conditions, please refer to the applicable insurance policy or check with your insurance professional. The illustrations, instructions and principles contained in the material are general in scope and, to the best of our knowledge, current at the time of publication.

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