Clinical trials in line with local laws.
Conducting clinical trials is a critical precursor to marketing a product – whether it involves obtaining approval for the sale of a new product or selling an existing product in a new territory.
But even before conducting the clinical trials, one must first obtain the approval of local ethics committees. This approval process includes a review of insurance documentation to ensure the involved parties are protected financially. In fact, many jurisdictions require specific insurance provisions by law or have local language requirements. Sometimes ethics committees go beyond those requirements.
We can help secure admitted clinical trials liability insurance in numerous countries around the world. Through an exclusive arrangement with W. R. Berkley Syndicate Ltd., we can help secure admitted clinical trials liability policies underwritten by members of Syndicate 1967 at Lloyd’s. Designed to meet local law and the most commonly requested or required specifications of local ethics committees, these admitted clinical trials liability policies can help ensure that clinical trials remain compliant with local laws.
Key features of this approach to providing global admitted clinical trials liability include:
- Policies are issued for the duration of the clinical trial; there is no need for renewal handling, and all premium will be billed up front
- While policies will be issued in the local language where required, full English versions of the policy or a policy digest will also be provided upon request
- The U.S. producer can be paid commission on issued policies under most circumstances
- While limits of insurance and deductibles will be addressed in the local currency as required in each country, premiums will be charged in US dollars wherever possible
To learn more, visit our Interactive Country Guide.