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 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

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 cover 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.