Policy snapshot
Clinical Trials Liability (CTL) Insurance protects the sponsor, investigator, and trial site from legal liability arising out of injuries or harm caused to participants during the conduct of clinical trials.
What is Clinical Trials Liability Insurance?
Clinical Trials Liability Insurance protects companies and investigators against claims from trial participants who suffer harm during research. It is mandatory for clinical trials in India.
What can it cover?
- The policy covers legal liability for injury, illness, or death of trial participants arising from the administration or testing of drugs, medical devices, or other interventions as part of the approved clinical trial. It includes compensation payable as per DCGI guidelines, legal costs incurred in defending claims, and related medical expenses. Coverage is typically defined per subject, per trial, and per occurrence. Extensions are available for multi-site or multi-country trials.
Who should consider it?
- Pharmaceutical and biotechnology companies, Contract Research Organizations (CROs), Hospitals, academic research institutions conducting trials, Principal Investigators (if not covered by sponsor)
Key features to understand
- {"heading": "Key Features", "bullets": ["Covers bodily injury, illness, or death of trial subjects", "Includes compensation, medical expenses, and legal defence costs", "Mandatory per DCGI (Drugs Controller General of India) for trials in India", "Policy issued per trial protocol, site, and number of participants", "Worldwide jurisdiction possible for multinational trials", "Can be extended to cover ethics committee liability"]}
What deserves attention before you buy?
Coverage, exclusions, sub-limits, deductibles, waiting periods, warranties and underwriting can vary between insurers and policy versions. The policy wording and schedule remain the definitive contract. Novo can help you review the relevant terms for your requirement.
Read the wording, not just the brochure
The schedule and policy wording determine the actual contract.
Compare meaningful differences
Look at exclusions, limits, deductibles, conditions and claim requirements—not premium alone.
Think beyond purchase
Servicing and claims-related support can matter as much as placement.