Medical device manufacturers
Clinical trials are the backbone of many medical advances, but they come with substantial risks. Not only are subjects sometimes at risk when participating in a trial, but the organization that administers the trial itself can face liability-related perils. Clinical trials insurance helps protect Massachusetts organizations that oversee clinical trials from some of the liability perils that they face.
Clinical trials insurance policies are highly specialized commercial policies that generally meet the needs of medical research labs and other organizations that administer clinical trials. Since these organizations are in a unique situation, it’s particularly important to work with a specialized insurance agent who knows clinical trials policies when selecting coverage.
In general, most organizations that administer, oversee or otherwise perform clinical trials and research studies in Massachusetts ought to consider purchasing clinical research insurance. Often, organizations are unable to run a trial without insurance in place.
Some examples of organizations that might need or want this insurance are:
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Precisely what an insurance policy covers is normally determined by that particular policy’s terms, conditions and exclusions, and clinical research policies aren’t an exception. Depending on a particular clinical research policy’s terms, it might cover a range of trials or only select ones.
Some clinical research policies will only cover federally approved research trials that have all the necessary paperwork filed. For instance, a trail may not be covered by a policy if the trials’ Investigational New Drug application or an exemption isn’t in place.
An insurance agent who’s familiar with these types of policies will be able to help organizations determine precisely what their clinical research policy covers and what requirements must be met so that coverage isn’t compromised.
Clinical research insurance policies are usually underwritten as liability-only policies, which means they typically provide protection in covered situations where an organization is sued by another party. Like most liability policies, a clinical research policy will likely help with legal costs and settlements associated with covered claims.
The risks that these policies help protect against can often be categorized into two categories:
Coverage for the first risk category may be termed “no-fault compensation.”
In most situations, organizations that need this insurance will want coverage for both categories of risks. An insurance agent can help confirm that a policy offers both types of protection.
If a provider or other employee is injured during a clinical trial, their injury probably won’t be covered by a clinical trials policy. Even if the injury is directly related to administering a vaccine or medication, such an incident would normally be treated as a workplace injury.
Workplace injuries usually fall under the domain of workers compensation insurance, which organizations are likely required to have but typically is distinct from a clinical trials policy. Clinical trials policies are usually focused on the liability risks that enrolling subjects in presents.
General liability policies normally protect against common risks, such as slip-and-fall accidents. While this insurance might cover a fall that a trial participant has on their way into or out of a facility, general liability usually won’t cover the trial-specific risks that come with clinical trials. If a participant has an adverse reaction to a medication, for instance, that probably won’t be covered by general liability.
A clinical trials policy is usually needed to cover trial-related risks.
For help finding clinical trials insurance that will keep your Massachusetts organization well-protected, contact the insurance agents at The Feingold Companies. Our independent agents are familiar with the nuances of these policies, and they can show you options from multiple insurance companies to help you secure the best available coverage