Research organizations or Manufacturer particularly Pharmaceuticals manufacturer carrying out clinical trials , face the risk of legal liability to pay research subjects (Participants / Patients ) for the death, bodily injury, physical or mental illness, disease or impairment caused due to the research or new medicines.
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.
Clinical Trials are vital and important for finding new, better & more effective Medicine. Whenever any new medicine/therapy is to be launched, it must first be tested in lab on animal or human cell. If the results are encouraging than it is tested on human being. India has now become a favourable destination for clinical Trials because of availability of expertise , infrastructure, availability of patient /research subject, low cost.
The Clinical Trials Insurance policy covers legal liability arising out of :
Some of the other highlights of the policy are: