Berkley Life Sciences (BLS) is dedicated exclusively to the life science industry. We offer deep expertise in clinical trials insurance both domestically and internationally. We provide global insurance solutions for companies exporting products or services overseas and for global organizations with established international operations.

Domestic Clinical Trial Liability Coverage

Our comprehensive domestic coverage includes:

• Bodily Injury & Property Damage coverage
• Blanket Clinical Trials coverage for approved clinical trials (please refer to policy wording for policy definitions).
• Errors & Omissions coverage
• Blanket Additional Insured coverage
• Personal & Advertising Injury liability coverage
• Abuse & Molestation liability coverage
• Medical Monitoring coverage
• No-Fault Medical Expense coverage

Additional Offerings

• The Berkley Life Sciences Critical Fact approach tells the policyholder what incidents or events they need to report to us. 
• There is no Known Circumstance/Deemed Known Exclusion.
• The Batching provision helps the policyholder preserve coverage for future claims related to a known critical fact event.

Watch our video for more details on the key features and benefits of our Clinical Trial Liability Coverage.

Foreign Clinical Trial Liability Coverage

The global clinical trials market has grown exponentially, with a significant increase in trials conducted outside the U.S., now valued in the billions. Leverage our expertise to navigate this complex landscape.

Our Approach to Foreign Clinical Trial (FCT) Insurance

Specialized Solutions: Foreign Clinical Trial (FCT) insurance can be complex, but Berkley Life Sciences excels in managing these challenges. Our LS Prime® specialty policies are integrated globally and complemented by local policies through Berkley affiliates, Network Partners, and Lloyd's Syndicate 1967.

Key Features of Our Global Network

• Expansive Reach— Our continually expanding network of Berkley-owned operations and local partnerships offers robust FCT insurance solutions in countries where most trials are conducted.
• Local Expertise— Our international specialists stay current with evolving regulations, ensuring accurate and up-to-date policy documentation. Certificates of Insurance can be issued in as little as 24 hours with a standard turnaround of 48 hours through our European Hub.
• Underwriting Expertise – Our underwriters are focused on life sciences, understand global risks, and customized solutions to meet unique needs. They are supported by specialists who are experienced in managing specific country nuances.

Coverage Details

We provide locally admitted policies in over 40 countries, available as standalone policies or as part of a Controlled Master Program with DIC/CIL coverage over local FCT policies. Click here for a list of available countries.

Determining Coverage Needs

When requesting clinical trial liability insurance, there are many considerations in determining coverage: 

• Is coverage compulsory?
• Does the country only permit admitted coverage?
• Are specific limits required?
• Are pre-and/or post-binding requirements in place (anti-money laundering criteria, wet signatures, pay before coverage, IPID needed, etc.)?
• Is a local servicing agent required?

Our streamlined process simplifies navigating different insurance requirements. Most premiums are quoted in U.S. dollars, and policies can be issued to cover the entire duration of the clinical trial. In many countries, English translations of foreign language certificates and policy forms are available for reference.

Additional Offerings

Berkley Life Sciences also provides products liability and package insurance for both domestic and global coverage to complement your clinical trial liability needs. For more information on our domestic coverage, please click here for products liability and click here for package. For more information on our global insurance solutions, please click here.