Even the most diligent trial sponsor can make missteps when it comes to identifying and obtaining the appropriate insurance coverage in a given country. Sponsors may inadvertently violate local insurance laws, expose themselves to excessive liability, or unknowingly purchase insurance limits well beyond the requirements of a particular country. The consequences can be severe. Problems related to inadequate insurance coverage can delay clinical trials, resulting in costly setbacks in the approval process and shortened patent protection periods.
Because of the complexity presented by foreign clinical trials, sponsors should work with an insurer that has experience not only in the United States but also around the world, and that can compliantly provide local insurance and claims expertise in the specific countries where the trial will be conducted.