Clinical trials – what you need to know
Chubb Commercial Insurance

Conducting clinical trials is a critical part of your company’s development. There are many complex regulatory issues to deal with and having the correct insurance is a big part of this. It is important you look into your insurance needs early on in the process. You may also need to consider that the availability and affordability of clinical trial insurance in various countries may have an impact on where you conduct the trial.

The protocols for a multi national clinical trial are complex and, therefore, often misunderstood. Whilst some countries have well documented compulsory insurance requirements outlining specific terms and conditions of the policy which must be in place, others do not.

Early collaboration with Chubb ensures that you have the insurance you need in plenty of time. And most importantly, we have over a decade of experience navigating the maze of such documentation requirements for clinical studies around the world.

The ethics committees of each worldwide location need a myriad of insurance documentation. Whilst regulations vary and are subject to change, the information required for each trial includes, but may not be limited to:

• Local sponsor information
• Protocol study information
• Local lead investigator information
• Insurance broker contact information
• Local legal representative information

We also find that once the documentation has been acquired, various problems can delay the process. Examples of these are:

• The ethics committee requiring local language versions of key clinical trial documents
• Frequent rejection of incomplete documentation by the ethics committee
• In some countries, in order for the insurance to become effective, the named insured must countersign the policy and return it to the insurance company

If you are embarking on human clinical trials, we advise that you contact your broker as early as possible to help reduce any errors and delays.

Chubb has a worldwide network of offices so we are uniquely qualified to help you with the accurate and timely issuance of a local admitted policy and certificate of insurance.