Chubb has issued an advisory to help U.S. life sciences firms understand the evolving legal and regulatory liabilities they may face when they conduct testing in foreign countries.
Co-authored by two Chubb executives, the advisory, “Managing the Insurance Complications of Foreign Clinical Trials,” discusses the complex risks and crucial regulatory concerns sponsors should be aware of when selecting trial locations abroad. According to the U.S. National Institutes of Health, nearly 60% of clinical trials for drugs and medical devices are conducted outside the U.S.
The advisory, which can be read here, offers insights into how sponsors can:
- manage risks through contractual arrangements with contract research organizations;
- respond to local regulatory concerns;
- navigate complex risks on a country-by-country basis; and
- obtain insurance coverage that complies with local requirements.