Clinical Trials Insurance
Liability cover for sponsors, CROs, investigators and trial sites
- No-Fault Compensation
- Legal Defence Costs
- Phase I to Phase IV
- CDSCO / NDCT Rules 2019
- Per-Trial or Blanket Cover
- Free Consultation
- No Obligation
- IRDAI Authorised Advisor
- Instant Quote
About this plan
Clinical Trials Insurance (also called Clinical Trials Liability or No-Fault Compensation cover) protects pharmaceutical companies, biotech firms, Contract Research Organisations (CROs), hospitals, principal investigators and ethics committees against claims arising from injury, illness or death of a human subject participating in a clinical trial. In India, sponsors must provide medical management and compensation to trial subjects under the New Drugs and Clinical Trials Rules, 2019, and CDSCO requires proof of insurance before approving a study. The policy funds that liability along with legal defence costs.
Key benefits
Why customers in Hyderabad choose this plan.
No-Fault Compensation
Pays compensation to the trial subject or legal heirs for trial-related injury or death even where no negligence is proved, as required under Indian regulations.
Legal Liability Protection
Covers damages and settlements the sponsor, CRO, investigator or institution becomes legally liable to pay to a trial subject.
Defence & Legal Costs
Funds lawyers, expert witnesses and court costs for defending claims, including proceedings before the Drugs Controller General of India.
Regulatory Compliance
Provides the insurance certificate CDSCO and the ethics committee require before the trial protocol is approved.
Multi-Party Cover
One policy can extend to the sponsor, CRO, each participating site, investigators and ethics committee members as additional insureds.
Flexible Structure
Cover a single protocol, or take a blanket annual policy across multiple studies and geographies with per-subject and aggregate limits.
Types of Clinical Trials Insurance plans
Pick the structure that matches your usage, budget and legal requirements.
Single Trial (Per-Protocol) Policy
Cover issued for one approved protocol, with limits set per subject and in the aggregate for the study.
Best for: Sponsors or CROs running one study at a time
Blanket / Annual Programme
One annual policy covering every trial the sponsor runs during the period, declared at inception or as they start.
Best for: Pharma companies with a continuous research pipeline
Site / Institution Policy
Cover bought by the hospital or research institute for the trials it hosts and the investigators it employs.
Best for: Hospitals and academic research centres
Multi-Country Programme
Worldwide or worldwide-excluding-USA/Canada territory with local certificates where the trial is run overseas.
Best for: Global studies with Indian sites
Optional add-on covers
Enhance your comprehensive policy with add-ons that plug the gaps in a standard cover. Availability depends on vehicle age and policy variant.
Extended Reporting Period
Report claims that surface months or years after the trial closes.
Higher Per-Subject Limit
Increase the compensation limit available for each enrolled subject.
Ethics Committee Cover
Name the ethics committee and its members as insured persons.
Medical Management Expenses
First-party funding of the subject's treatment for trial-related injury.
Worldwide Jurisdiction
Extend defence and damages to claims filed outside Indian courts.
Key features
- Cover for Phase I, II, III and IV trials, plus bioavailability and bioequivalence studies
- Compensation as per the CDSCO formula for trial-related injury and death
- Medical management expenses for the trial subject
- Sponsor, CRO, investigator, institution and ethics committee as insured parties
- Per-subject limit and policy aggregate limit chosen by the sponsor
- Territory and jurisdiction options for India-only or multi-country studies
- Extended reporting (discovery) period after the trial ends
- Retroactive cover for trials already under way, subject to underwriting
What's covered
- Bodily injury, illness or death of a trial subject caused by the trial drug, device or procedure
- No-fault compensation payable under the New Drugs and Clinical Trials Rules, 2019
- Legal defence, investigation and settlement costs
- Claims from placebo-arm subjects where injury is trial-related
- Liability of the institution and investigator for protocol-approved procedures
- Costs of representing the sponsor before regulators and ethics committees
Common exclusions
- Deliberate deviation from the approved trial protocol or Good Clinical Practice
- Trials conducted without CDSCO and ethics committee approval
- Injury arising from the subject's underlying disease and unrelated to the trial
- Known and disclosed side effects that the subject accepted in informed consent, where the policy so states
- Fines, penalties and punitive damages
- Product liability after commercial launch of the drug or device
- War, terrorism, nuclear risks and intentional criminal acts
Frequently asked questions
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