Medical device manufacturers and drug development organizations that perform clinical trials are usually required to hold some sort of clinical trial coverage. However, not all clinical trial coverage policies are created equal. The insured parties need to purchase an exhaustive policy that will cover any and all liabilities connected to clinical trials.
Be Selective About Your Life Sciences Policy
Nowadays, medical research laws often require life science companies to provide locally admitted insurance coverage, along with specifically worded policies. Pharmaceutical companies and device manufacturers, therefore, need to choose insurance carriers that specialize in this coverage and provide the international capability to handle clinical trials worldwide.
Since clinical trials are subject to a bevy of state and federal regulations, you need to make sure your insurance company structures a policy that meets these regulations.
Of course, the sponsors of clinical trials must devise ironclad contracts that discourage legal action. Contracts that have favorable language can indemnify the sponsors of clinical trials and absolve and pass liability on to guilty parties.
Also, favorable contracts clarify who is responsible in the case of a claim. Clinical trial sponsors with strong contracts are more attractive to underwriters, and can therefore secure lower premiums and higher limits of coverage.
Business Advantages to Clinical Trial Insurance
Good clinical trial insurance not only protects you from liability, it also makes you more attractive to investors by demonstrating that you are prudently handling your life science research endeavors.
Insurance companies limit clinical trials insurance to the exact trial or products that are being tested. Therefore, it’s especially important to clearly list the components of any trial when applying for clinical trial insurance.
Never Underestimate Coverage Limits
Many clinical trials sponsors are unsure as to how much insurance to buy. Generally, clinical trials policies should carry a minimum coverage limit of $1 million, but this number can range up to $20 million or more, depending on the device or drug involved in the trial.
Clinical trial sponsors also need to understand the policy coverage, endorsements and exclusions to assure that they are purchasing the appropriate clinical trials insurance for their needs.
All in all, clinical trials are risky endeavors, making good clinical trial insurance a complete necessity for the clinical trial sponsors.
Protect yourself and your company with comprehensive clinical trial coverage.
