Who Needs a Clinical Trial Policy?
In most cases, any organization involved in a clinical trial needs a clinical trial policy. Drug development companies, medical device manufacturers and research groups with new treatments all need protection in case the trial doesn’t go as planned, and their drug, device, or treatment causes damage or harm.
Clinical research organizations and site management organizations need protection against potential breaches of their professional duties and accidents that might happen at the trial site. They often need both general and professional liability coverage, which together may provide coverage for everything from a fall on a stairwell to an incident involving direct contact between a provider and patient. Although these coverages are different, they’re often combined as an organization typically needs them to be into one clinical trial policy that provides robust coverage against many of the risks that trial sponsors and administrators face.
Why Do Sponsors and Administrators Need a Clinical Trial Policy?
Sponsors and administrators of clinical trials need a clinical trial policy for two reasons.
First, even though clinical trial participants often sign waivers, these documents do not absolve sponsors and administrators of all responsibility. A clinical trial policy can help provide protection where an organization maintains responsibility. For instance, a waiver usually doesn’t relieve an organization of liability if there is a breach of professional duties -- but a clinical trial policy might provide coverage for the breach (this is just one example; exact needs vary depending on the circumstances surrounding a clinical trial).
Second, organizations are often required to have a clinical trial policy in place before they begin a trial. The approval process typically stalls at the clinical trial phase if an organization doesn’t have coverage, only proceeding once a policy has been obtained.
How Can Organizations Get a Clinical Trial Policy in Massachusetts?
Because clinical trial insurance is a specialized form of insurance and policies must be tailored, sponsors and administrators should look for an insurance agency in Massachusetts that is knowledgeable about this specific form of insurance. An independent agency that has worked with organizations that have needed clinical trial policies in the past will be able to help identify coverage needs and find a customized policy that meets those needs.
We Understand The Clinical Trial Process
Getting a new medical drug, device, or treatment approved usually requires completing several clinical trials. These trials contain a level of inherent risk, as the drugs, devices, or procedures being studied are, by definition, experimental until the trials are completed. Clinical trial insurance provides sponsors and administrators of clinical trials in Massachusetts with important protections against the potential risks that they may face when conducting clinical trials.
