Avoid insurance complications in foreign clinical trials

Clinical trial sponsors conduct trials overseas for a variety of reasons. Without a detailed understanding of the local insurance regulations and an appreciation for how to mitigate and transfer risk properly, however, even the most diligent sponsor can make a misstep that heightens their potential liabilities or increases the risk of costly delays.

Biotechnology, pharmaceutical and medical device companies choose to sponsor clinical trials in other countries for a variety of reasons. The disease may be endemic to that region; trial data from a country may be required before the drug or device can be approved for sale there; it might be difficult to find an adequate pool of treatment-naïve U.S. trial participants; and comparable medical facilities may be available at a more competitive cost. While there may be compelling reasons to pursue a foreign trial, sponsors should ensure they have a well-designed, coordinated, regulatorily compliant global insurance program, coupled with a strong risk management process. Each host country has its own insurance laws, and the specific insurance requirements for clinical trials can vary greatly.