The Risk

Organizations carrying out clinical trials face the risk of legally liability to pay research subjects for death, bodily injury, physical or mental illness, disease or impairment caused to research subject as damages by the research.

The Solution

Clinical Trial Liability Insurance (CTLI) provides cover against legal liability arising out of lack of care, negligence resulting in injury or death of the subject. Insufficient/improper disclosure and conflict of interest may also become subject matter of suit.

The Cover

This policy will indemnify the insured against all sums for which he will be legally liable pay to any Research Subjects as for death bodily injury physical or mental illness disease or impairment caused to Research Subject as damages for death bodily injury physical or mental illness disease or impairment caused to Research subject by the research. The policy will also pay for the costs & expenses incurred by the Insured in connection with the defence or settlement of any claim.

This insurance applies if the notice of claim, which takes place in coverage territory, has been given to the insurance company in the Policy Period. However such notice period can be extended post trial. The policy can be single trial policy or it may be multi-trial policy covering several trials of the policyholder. For the purpose of rating, the most important aspect to look into is the track record of the sponsoring company and others involved in conducting the trial. The company must establish and maintain a policy of adherence to the required clinical trials protocol and must not stray from safety norms. Fulfillment of informed consent rules must be ensured. Parties to the clinical trial must sign clinical trial agreement for strict adherence to the protocol and to take care of other concerns.

For Further Information Contact:

Mr Vibhaw Kumar

Senior Vice President – Liability & Special Risks


+91-22-6655 8810