Clinical Trials Liability Insurance

Growing competition in the drugs & pharma industries is driving companies to find solutions or cures to large scale diseases or degenerative conditions. In this environment the commercial advantages to the firm that produces the first approved drug for a disease that affects a large patient population can be enormous. At the same time, the liabilities associated with trials can be significant for all of the parties involved in the trial.

All clinical trials must first be pre-approved by the regulatory body through the submission of a detailed clinical test protocol to that regulatory body. Finally, every human subject in a clinical trial must review and sign a detailed patient-informed consent document. Nonetheless, these measures may not provide absolute protection against legal liability‚ÄĒespecially if one of them is not properly satisfied.

Failing to uphold rigorous standards for their clinical trials, sponsor companies may expose themselves to the threat of costly litigation. Clinical trials liability insurance can help protect pharmaceutical companies from some of the expenses associated with a liability lawsuit. But companies with poor risk management practices may experience difficulty obtaining such insurance, and/or may have to pay more for less protection.