
Clinical Trials Liability Policy
Ensuring Protection Against Risks in Clinical Research
Clinical trials play a crucial role in medical advancements but come with inherent risks. Clinical Trials Liability Insurance safeguards sponsors, researchers, and institutions against legal liabilities arising from trial-related injuries or claims. This coverage ensures financial protection and legal defense, making trials more secure and compliant.
Key Benefits
- Protection against legal claims from trial participants
- Coverage for compensation and damages awarded by courts
- Legal defense cost reimbursement
- Compliance with regulatory requirements for clinical trials
- Coverage for medical expenses due to trial-related injuries
Health Cover Up
to ₹50 Lacs
What is Clinical Trials Liability Policy?
A Clinical Trials Liability Insurance Policy provides financial and legal protection to sponsors, researchers, and institutions conducting clinical trials. It covers claims arising from participant injuries, legal defense costs, and compensation liabilities, ensuring compliance and smooth trial execution.
Why do you need Clinical Trials Liability Policy?


Protects Against Participant Injury
Ensures coverage for medical costs and compensation in case of trial-related injuries.

Covers Legal Defense Costs
Protects against expensive legal fees in case of lawsuits from participants or regulators.

Ensures Regulatory Compliance
Helps meet legal requirements and avoid penalties or fines for non-compliance.

Safeguards Financial Interests
Provides financial protection for sponsors and institutions against costly liabilities.
Why choose Insurance Manager to protect your business?

Comprehensive Protection for Your Workforce
Ensure employee well-being with complete health insurance coverage.
Comprehensive Protection for Your Workforce
Ensure employee well-being with complete health insurance coverage.
Cost-Effective Group Insurance Plans
Affordable plans with benefits like maternity, critical illness, and dependent coverage.

Cost-Effective Group Insurance Plans
Affordable plans with benefits like maternity, critical illness, and dependent coverage.
Peace of Mind for Employers and Employees
Reduce financial stress with cashless claims and reimbursement options.

Peace of Mind for Employers and Employees
Reduce financial stress with cashless claims and reimbursement options.
Boost Employee Productivity and Retention
Build loyalty and motivation by easing economic and mental burdens.

Boost Employee Productivity and Retention
Build loyalty and motivation by easing economic and mental burdens.





What does Clinical Trials Liability Policy cover and exclude?
Plan Coverage
Bodily Injury to Participants
Covers medical expenses and compensation for injuries caused during the trial.
Legal Costs & Expenses
Provides coverage for legal fees incurred while defending against claims.
Retroactive Coverage
Includes claims related to incidents that occurred after the retroactive date specified in the policy.
Claims from Research Subjects
Covers claims filed by research participants for bodily injuries or adverse reactions.
Third-Party Liability
Protects against claims made by third parties affected by the trial's operations.
Compensation for Damages
Provides compensation for damages awarded by courts in favor of the claimant.
Medical Expenses
Covers the cost of medical treatment for injuries or adverse reactions from the trial.
Trial-Related Incidents
Covers any incidents arising out of the clinical trial activities as stated in the policy schedule.
- In-patient treatment 24 hours a day
- Pre-existing disease
- Pre and Post hospitalization
- Domiciliary hospitalization expenses
- Reimbursement of cost of health check-up
- All day care procedure
- Family floater to covers member’s immediate family such as a spouse, dependent children, dependent parents, etc.
- Maternity benefits
- Dental treatment
- Cost of spectacles, contact lenses
- Waiver of waiting period
- Waiver of first-year exclusions
- Reimbursement of ambulance costs
- Baby day one care
- Vaccination benefits
- Increased room rent limits
- Corporate buffer
- Out-patient treatment (OPD Card)
- Root canal surgery
- In-hospitalization expenses due to sickness or accidents
- Room and boarding expenses as provided by the hospital/nursing home.
- Nursing expenses.
- Surgeon, anesthetist, medical practitioner, consultants or specialist fees.
- Anesthesia, blood, oxygen, operation theatre charges, surgical appliances, medicines and drugs, diagnostic materials and X-Ray, dialysis or chemotherapy.
Major Exclusions
Pre-Existing Medical Conditions
Excludes injuries or conditions that would have occurred or persisted without participation in the trial.
Genetic Damage
Does not cover genetic damage, mutations, or alterations caused by the clinical trial.
Deliberate Acts by Participants
Excludes injuries resulting from a research subject's intentional actions against instructions.
Addiction Development
Excludes bodily injuries arising from the development of addiction due to the clinical trial.
Punitive or Exemplary Damages
Excludes damages that are punitive or exemplary under foreign law or special legal frameworks.
Immaterial Damages (Pain & Suffering)
Does not cover compensation for immaterial damages like pain and suffering.
Uninformed Risk of Medical Effects
Excludes injuries from inevitable effects that the subject was not informed of.
Severity Beyond Medical Acceptability
Does not cover injuries exceeding the severity deemed acceptable in medical science.
- If the appropriate waiver is not opted for, then the policy will not cover
- Treatment of pre-existing illnesses.
- Any treatment for illnesses/diseases within the first 30 days of the policy, unless it is an accident.
- Treatment of specified illnesses for the first year of the policy.
- Certain diseases like hernia, cataract, piles, sinusitis, etc are excluded during the first year of operation in the cover.
- Any claim arising out of or traceable to pregnancy.
- Ayurvedic, homeopathy, naturopathy or any other form of local medication.
- Alcoholism, drug abuse, and AIDS.
- Dental treatment or surgery unless it requires hospitalization.
- Cost of spectacles.
- Vaccination and inoculation.
- Cosmetic treatment.
Your Journey to Insurance Manager

When can I Claim?
A claim under Clinical Trials Liability Policy can be registered in the below circumstances:
- Claims for injury or adverse reactions during the trial.
- Legal actions filed by participants for trial-related harm.
- Claims due to regulatory non-compliance or violations.
Claim what’s yours with Insurance Manager
Have more questions?


Submission

Assessment
