Clinical Trial Insurance

What if a high dosage of a drug under trial, negligently administered to your participants results in some bodily impairment?

What if the new drug introduced by your company causes loss of life of persons under trial?

However much thought-through your protocol design may be, clinical trial insurance is a must. It can help you save your finances and reputation from losing face to legal proceedings and judgments arising out of lack of care, negligence resulting in injury or death of the subject. Such insurances are however, never one size fits all! We at Sivana, ensure you get a tailor made insurance that suits your specific requirements and provides appropriate coverage.

Who should buy clinical trial insurance?

Director or partner/sponsor of the insured

Employees of the insured including medical staff/doctors

Any past employee who worked in the trial for the insured

Any sub-contracted doctor/nurse/consultant/physician/hospital or contract research organization

Who is Covered?

Director or partner/sponsor of the insured

Employees of the insuredincluding medical staff/doctors

Any past employee who worked in the trial for the insured

Any sub-contracted doctor/nurse/consultant/physician/hospital or contract research organization

What could possibly result in a liability?

Failure to perform as per the contract

Failure to monitor properly

Failure to report negative information

Failure to provide adequate information

Defective drug supplied by the manufacturer

Fault in study protocol

Negligent act by the investigator or medical staff

Unsuitable surroundings of the hospital/medical centre

Can I buy?

One trial one policy?

Many trials one policy?

Trial started last year, policy required now?

Trials at various locations?

What is covered and what is NOT?

The clinical trial insurance covers the following:

Settlement by mutual consent

Every claim where legal liability is established

Cost of defending a lawsuit for admissible claim

While buying clinical trial insurance, ensure that:

All sites are insured

All subjects are declared to the insurer

Adequate sum insured is available for the claimant

The policy covers duration of complete trial

Policy wordings are carefully understood

Medical negligence cover has been opted for, under the professional indemnity extension

An insurance broker is consulted to safely sail you through this with his/her expert knowledge on the subject!

The clinical trial insurance does NOT covers the following:

Pain and suffering.

Claim arising prior to the retroactive date.

Medical malpractice.

Inefficacy of the clinical test.

Punitive or exemplary damages, fine, penalties or costs of compliance.

Injury sustained by any employee.

Deterioration of health that would have existed irrespective of participation in the trial.

Did You Know?

The Central Drug Standard Control Organization has mandated that all trials must have appropriate insurance covers prior to the commencement of clinical trials.

The policy should cover ANY bodily injury/property damage to a third party arising due to the clinical trial.

The clinical trial is restricted to living human beings and would not include animals and resultant claims from owners of such pet animals.

There is a distinction between a product liability insurance which is for a finished product and a clinical trial liability insurance which is applicable for products which are still in research stage.

Professional indemnity insurance of medical establishments/doctor does not cover clinical trials and health insurance policies do not cover hospitalization of trial subjects.