When considering an insurance plan, a biomedical or medical device company must take it's clinical trial risks into special consideration. The clinical trial liability is a specific, high-risk area that requires unique coverage to provide the maximum insurance protection. A company needs to purchase additional liability insurance specifically designed to cover clinical trials.
The terminology and design of clinical trial liability insurance can be different from policy to policy; knowing exactly where a company does and does not have coverage can mean the difference of millions of dollars in a potential judgment.
Finding the right insurance plan for clinical trial liability can be difficult and time-consuming, but it is crucial. In the long run, selecting the best plan will save the company time and money. Good clinical trial insurance not only protects the company from liability exposure, it also provides an increased level of comfort for investors by demonstrating prudent financial management and accountability.
In many cases, a company needs clinical trial liability coverage in addition to its general liability and products liability coverage. Clinical trial insurance is a highly specialized product, and as a result, not every carrier can fulfil the needs of companies searching for such specific coverage. Although there are occasional reasons to use separate insurers, it is generally safer to have both product liability and clinical trial coverage with the one provider, by going so, this avoids coverage disputes over claims, and reduces and ultimately the possibility of gaps in coverage.
The insurance is limited to the clearly specified trials of clearly listed products and for no other tests or products.
In some countries, it's obligatory for companies to establish minimum coverage limits, but in others, there is no set rule for establishing coverage limits or minimums, but the consensus in the insurance community is that a clinical trials liability policy should carry a minimum limit of $1 million and can have upper limits of $10 million through $20 million or more. Of course, a company's specific needs—and sometimes the needs of the testing facility and its risk.
Clinical trials bring with them substantial risk, and unavoidable accidents can occur. Companies that take the time to obtain the right clinical trials liability insurance will find it well worth the effort. Failure to do so exposes the company to needless risk and can cost valuable time and money as well as other resources.