PINC Pioneer Insurance & Reinsurance Brokers Pvt Ltd
Clinical Trial Insurance Clinical Trial Liability Insurance (CTLI) basically covers 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
Stakeholders in Clinical Trials Sponsor CRO (Contract Research Organizat ion) also ethics committees — mostIy affiliated to hospitals — that approves a trial and carries the onus of ensuring subject safety
Scope of Coverages Liability resulting in bodily injury/death to the Research subject Legal cost and expenses including defence cost Settlement with mediator Exte nded Reporting period
Exclusion No Cover for Trial Carried out before Policy inception date Punitive and Exemplary damages and damages which are not in direct relation with the Clinical Trail Exclusion Genetic Damages Exclusion Absolute Cyber Liability Exclusion Product Inefficacy exclusion Professional Indemnity exclusion