Clinical Trial Liability
Clinical Trial Insurance provides indemnity against legal liability to any Research Subject for death, bodily injury, physical or mental illness or disability caused during the clinical trial studies. Companies that carry out clinical studies on research subject like Pharma Companies, Clinical Research Organisations (CROs), Hospitals are required to take this policy. The policy can be for a single trial or multi-trial policy covering several trials during the year.
The premium is dependant on various factors like:
- Nature of the drug and criticality of application
- Stage of Trial - Phase 1 to Phase IV or Bio-Equivalence Studies
- Duration of Study
- Follow-up Period of study
- Nos. of Subjects, their age profile and
- Whether studies are conducted in India or Outside India.
- Prevailing laws of minimum premium outside India geographies
- Sponsor Company or CROs experience
The policy also pays for the costs and expenses incurred towards defending the claim.
Disclaimer: above is a broad indication. The actual available are as described in the policy wordings of the insurance company and will be subject to the policy terms, conditions and exclusions.