Human Clinical Trials

The research, development,  manufacture and marketing of life-saving products require life science companies to conduct human clinical trials. Medical device manufacturers, pharmaceutical manufacturers and contract research organizations, in particular, are frequently involved in conducting such trials to determine whether new products or new uses for existing products are safe and effective. Whether an insured is conducting small, local trials or large, multinational studies, Berkley Life Sciences’ LS Prime® clinical trial liability coverage is customized to the needs of life science companies.

Policies can address:

  • Clinical trial liability coverage: claims for bodily injury, property damage and personal injury caused by, or directly resulting from, participation in an approved clinical trial.
  • Abuse and molestation coverage: Allegations that the insured’s negligent employment, investigation, supervision or retention of others led to sexual abuse or molestation of clinical trial participants causing bodily injury or personal injury.
  • Medical expense coverage: protects the policyholder from unexpected medical expenses associated with a clinical trial. Optional stop loss coverage eliminates the need to first submit a claim to the participant’s health

The LS Prime® policy includes the following features, specifically tailored for the life science customer:

  • Worldwide coverage territory: Difference in Conditions and Excess coverage provided over local policies placed in compliance with compulsory coverage requirements.
  • True blanket coverage: clinical trials are covered on a blanket basis, so there is no need to schedule each trial separately.
  • LS Prime® has eliminated many clinical trial broad-based exclusions, such as exclusions for minors; cognitively impaired individuals; pregnant women; prisoners; or new product indications.

For information regarding our LS Prime® Blanket Clinical Trials coverage, please click here.

Foreign clinical trials

Clinical trials conducted overseas differ in several important key respects from those conducted in the United States.  Berkley Life Sciences can help U.S. domiciled insureds secure local clinical trials liability insurance in numerous countries around the world, including admitted local coverage where needed.  These policies are designed to meet local requirements, comply with local laws and include the most commonly requested or required specifications of ethics committees.

Berkley Global Underwriters, Coverholder at Lloyd’s

Berkley Life Sciences issues and services local placements through a coverholder arrangement with Lloyd’s of London, thereby allowing us to extend our reach to roughly 40 countries.  Key features of Lloyd’s policies include:

  • Policies are issued for the duration of the clinical trial: there is no need for renewal handling and all premiums will be billed at inception.
  • While policies will be issued in the local language where required, full English versions of the policy and/or a policy digest will also be provided upon request.
  • The United States producer can be paid commission on issued policies under most circumstances.
  • While limits of insurance and deductibles will be defined in the local currency as required in each country, premiums will be charged in U.S. dollars wherever possible.
  • Certificate and policy documents for foreign clinical trials through Lloyd’s are issued quickly and accurately from our US offices – minimizing time zone and holiday conflicts.

Berkley Life Sciences is able to further extend its global reach to additional countries through international affiliates of the W.R. Berkley Corporation, as well as a number of network partners.