Clinical Trials Liability Policy

Clinical Trials Liability Policy

MHDI's Clinical Trial Liability Policy provides protection against legal liabilities arising out of clinical trial. The policy not only provides coverage against suits and damages awarded by courts but also covers the defence costs incurred by them while contesting such claims of liability damages.

Clinical Trials insurance solutions provide protection for the sponsors/ organizers of clinical trials, covering their legal liability to pay compensation in the event of an injury to a trial participant

Coverage
exists for liability of all phases of clinical trials for drugs and medical devices as well as non-compulsory studies arising from:

  • negligent harm to trial participants
  • no-fault compensation
This policy does not cover liability for:
  • Bodily injury of a research subject (patient) provided that person suffers from a medical condition the treatment of which is the object of the investigated pharmaceutical and provided that this bodily injury is caused by inevitably occurring effects /events of which the research subject has been informed and does not exceed a limit of severity deemed acceptable in medical science.
  • Bodily injury and exacerbation of a pre-existing bodily injury which would have occurred or persisted even if the research subject had not participated in the insured clinical trial.
  • Genetic damage.
  • Bodily injury of a research subject due to his deliberate act contrary to the explicit instructions of the persons assigned to conduct the insured clinical trial.
  • Bodily injury arising from the development of an addiction as the consequence of an insured clinical trial.
  • Expenses as a result of unwanted pregnancy /wrongful conception as the consequence of an insured clinical trial
  • Punitive and/or exemplary damages and other according to foreign law potential claims and calculation methods.
  • Compensation of immaterial damages (e.g. damages for pain and suffering).