January 2014

Global Clinical Trial Insurance

Designing an insurance program for a global clinical trial is an exceptionally complex task. Exposure to experimental products presents a multitude of risks for all stakeholders, be they institutions, investigators, contract research organisations (CROs), sponsors, ethics committees (ECs) / institutional review boards and/or trial participants themselves.

Unfortunately, risks are unavoidable in any clinical trial. Even with comprehensive preclinical research and high-quality study design, conduct and monitoring, risks such as bodily injury to participants and/or financial and reputation risk to trial stakeholders (through legal proceedings and judgments) are a possibility. However, these risks can be mitigated or transferred through a well-designed insurance program.

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