Q&A: International Clinical Trials - Why Specialized Expertise Matters

Frédérique Roumengous, Manager, Biomedic-Insure

Q: Can you provide us with some background on Biomedic-Insure?

Frédérique Roumengous: Biomedic-Insure is an insurance brokerage company that procures clinical trials liability insurance for medical technology and life sciences companies conducting clinical trials in countries which have mandatory local insurance requirements. We have a specialized staff that includes two medical doctors, well-versed in life sciences and medicine.

Since our founding in 1990, we've placed 18,000 liability policies for companies conducting clinical trials. The trial sponsors we have worked with have ranged in size from clinical trial stage firms, middle sized enterprises, and large multi-national organizations, so we are very familiar with a wide range of needs that companies may experience throughout their lifecycles.

Q: As Biomedic-Insure is headquartered in Paris, what's the best way for a U.S. company access your services?

FR: We are part of Verlingue, Courtier en Assurances, the ninth largest independent broker with ten locations in France, two in the UK and operations in more than sixty countries through partners in the Worldwide Broker Network (WBN, www.wbnglobal.com). U.S. companies can reach us through their local broker or, in certain circumstances, some companies can establish a direct connection with us.

Q: Why do brokers partner with Biomedic-Insure to offer clinical trial insurance to their clients?

FR: Coordinating clinical trial insurance placements is quite a complex process, as was described in the article "Insurance Considerations for Global Clinical Trials." This is particularly true for brokers who are not familiar with local requirements or who are unable to keep up with insurance law changes that are constantly evolving in countries throughout the world. Biomedic-Insure lends valuable assistance to brokers by making the insurance procurement process simple, clear, efficient, and accessible.

Q: How do you partner with brokers to serve their clients in this area?

FR: As an international clinical trials liability specialist, we become an extension of their expertise and their ability to provide solutions for clients. In many situations, one policy will not be sufficient to meet local requirements in various countries or satisfy the prerequisites of all ethics committees. Insurance protection that satisfies the protocols in one country may fail to meet the insurance protocols in another jurisdiction. These situations often cause delays and cancellations of clinical trials. It is in these types of complicated situations where we can really help a broker.

It is important to keep in mind that if the insurance placements are not properly coordinated, it's possible that there will be coverage gaps that leave the client with no insurance protection. We help brokers work globally to protect their clients from such situations.

Q: You say that client advocacy is an important part of what Biomedic- Insure offers. Can you describe that?

FR: First, we make sure each client has the correct solution and that it is delivered promptly.

Second, when clinical trial test subjects make claims against the companies we help insure, we act as an advocate for those companies on all matters involving the claim to make sure they are properly handled. For example, insurance companies providing clinical trial liability policies may question whether there is a link between the injury to the patient and his or her participation in the trial. In these instances the expertise of the Biomedic-Insure medical team helps carriers reconsider their doubt and reach amicable resolutions of these claims.

Since we are an insurance brokerage firm, we know and understand how important it is to look after these two key interests of clients.

Q: How should interested U.S. brokers contact you?

FR: The most efficient way for brokers in the U.S. to contact us is to send an email message to: biomail@biomedic-insure.com or maryvonne.sevestre@biomedic-insure.com.

Frédérique Roumengous is currently Manager of Biomedic-Insure and has been part of the executive committee since 2007. She joined Verlingue in 2004, holding several key management functions in corporate risks and liability.

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