The commercial advantage of being the first to launch a medicine makes the risk of clinical trial necessary. Despite all precautions, the involvement of human subjects exposes the trial to risks relating to injury, disability or death. Any incident is bound to result in a liability suit. It covers a design risk of a specified trial protocol. Companies conducting clinical trial need proper monitoring of subjects to mitigate risk and a robust insurance cover to protect from all liabilities inherent to their risk management philosophy.
Research Subject Cover
Covers Liability or compensation arising from bodily injury or death of a research subject of the trial. The trial should follow the approved protocol and have informed subject consent. It is often difficult to ascertain the cause and insurance is mostly a no fault liability cover.
Broad Insured Cover
It covers directors or partners, employee or past employee acting for the institution including medical Persons who are employees. It also covers investigators, sponsors, sub-contractor, doctor, nurse, hospital or contract research organization and members of Ethics Committee.
Apart from liability and legal expenses the insurance can be extended to cover the medical expenses for treating the subject. The cover needs a comprehensive geographical cover and research subject defined to include their dependent, heirs, administrator and legal representatives.