INSURANCE & RISK MANAGEMENT: For Global Human Clinical Trials
April 8, 2011: By Daniel Brettler, Senior Vice President, Conner Strong
Often overlooked in the early planning of a human clinical trial, insurance requirements specific to foreign jurisdictions may have a significant impact on a company’s clinical program and a material impact on its bottom line. The clinical impact may include delay in enrollment as well as a decision not to enroll at all in a particular country from a cost/benefit perspective. Historically, the costs to secure insurance meeting local requirements were insignificant and therefore typically not strategic to the clinical trials planning process. An evolution has taken place in recent years outside of the United States whereby a more uniform approach to protecting patients in human clinical trials has prevailed and continues to gain momentum in just about every country today. This movement towards uniform protection has created a complexity of risk management and insurance issues for both insurance company and life science company alike. Read more