When your research is ready for the clinical trial phase, even if you are planning to obtain 510(k) approval, having the precise mix of insurance coverage is vital. Clinical trial insurance is often a required component in the approval process. However, many clinical trial companies mistakenly believe that they’ve protected themselves from liability with informed consent forms. The reality is that you can still be sued and found negligent even with these forms in place.
And, if an injury occurs during clinical trials, adverse results may include medical payment expenses; public and regulatory scrutiny; personal injury and errors and omissions lawsuits; and even criminal indictments. All of these are in addition to damaged reputations; difficulty in recruiting for future trials; interruption of the trial itself; delays in product launch; and increased insurance rates and/or difficulty obtaining coverage.
Having adequate and properly executed coverage will not only protect the sponsor from these risks, but also investors, investigators and other parties involved in the clinical trial’s management. Our highly trained and experienced staff can help you improve your ability to move forward with your clinical trial in a timely manner. We will negotiate customized coverage extensions with financially sound clinical trial insurance providers. Furthermore, we offer global capabilities to provide your clinical trial company with worldwide coverage and claims handling.