Companies in the life sciences industry are focused on innovations that save lives and improve the quality of life for all of us. With advanced technologies, intense regulation and the special risks that come from working with human specimens, these companies need an insurance broker that understands the industry inside and out.
It has been IMA’s experience that many life science companies struggle with the placement of clinical trial insurance due to poor counsel from their insurance broker. Many times the lack of counsel comes from a misunderstanding of the admitted versus non-admitted insurance requirements, as well as statutory limit requirements for clinical trials in various countries around the world.
When it comes to insurance for clinical trials, requirements vary from country to country, making the process of securing adequate insurance frustrating and confusing. Failing to think through the insurance issues early in the trial planning process can result in costly delays.
When considered early on, insurance requirements and its availability may bear some influence on how and where a study is conducted. Too often, sponsors of clinical trials do not consider insurance implications until it is time to provide the ethics committee an insurance certificate, and by that time it may be too late.
Exasperating the problem, as the trend toward overseas trials accelerates, is the fact that foreign countries are becoming more litigious, and many governments are making insurance an important piece of the regulatory process. Among countries with compulsory insurance laws, the minimum requirements vary widely. Complicating matters further, many times the ethic committees involved with the approval of a study have different interpretations of what compulsory insurance laws actually require. Insurance and regulatory requirements change frequently, and it is important to have a broker that stays on top of the latest changes to provide proper guidance and counsel when determining where to conduct a trial.
IMA believes that the most important aspect of dealing with clinical trials is to be proactive and well in front of the actual date of a scheduled trial. There are so many moving parts to a trial that the last thing you want to worry about is how to place the appropriate insurance coverage.
Having an expert life sciences broker is paramount to minimizing your exposure to loss, and IMA will work with you to:
- Review the protocol and craft an insurance program that meets the needs of the specific trial.
- Provide another set of eyes to review the informed consent.
- Determine what, if any, statutory insurance requirements need to be met on foreign clinical trials.
- Provide additional Risk Management insight to help you further mitigate your exposure on a given clinical trial.
- Make sure there are no “loop holes” between the coverage for the clinical trial and the DIC/DIL program.