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Foreign Clinical Trials Sponsors Face Complex Liability Threats and Regulations, Chubb Advises

By: via PR Newswire

PHILADELPHIA, June 1, 2016 /PRNewswire/ -- 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 clinical trials in foreign countries. 

Chubb (PRNewsFoto/Chubb)

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 percent of clinical trials for drugs and medical devices are conducted outside the United States.

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.

"In their quest to find a cure or prevent the spread of disease, life science companies often must take their research across borders as a result of the regional nature of certain epidemics, economic factors and the need to find an adequate number of trial participants," said Frank Goudsmit, Senior Vice President, Chubb Life Sciences Industry Practice, who co-authored the advisory with Lou Butler, Assistant Vice President, Chubb Global Services. "Faced with numerous complicated liability exposures, which are compounded by a patchwork of local laws and regulations, these trial sponsors need to implement a prudent risk management strategy that protects their patients and companies."

About Chubb

Chubb is the world's largest publicly traded property and casualty insurance company. With operations in 54 countries, Chubb provides commercial and personal property and casualty insurance, personal accident and supplemental health insurance, reinsurance and life insurance to a diverse group of clients. The company is distinguished by its extensive product and service offerings, broad distribution capabilities, exceptional financial strength, underwriting excellence, superior claims handling expertise and local operations globally. Parent company Chubb Limited is listed on the New York Stock Exchange (NYSE: CB) and is a component of the S&P 500 index. Chubb maintains executive offices in Zurich, New York, London and other locations, and employs approximately 31,000 people worldwide. Additional information can be found at:

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