The insurance company will pay the damage the insured becomes legally obligated to pay by reason of liability imposed by law/contract and first made in writing against the insured within the insurance period arising out of the following Specified Offenses committed by or on behalf of the insured:

• Products Liability: The subject's bodily injury/death as a direct result from the usage of the insured products during the trial.
• Professional Liability: With respect to Bodily injury/death arising out of malpractice, negligent act, error or omission in the rendering of professional services in connection with Human Clinical Trial.

》Who should apply for Human Clinical Trial Insurance？

• The manufacturers of pharmaceuticals
• The sponsors/hospital of Human clinical trial practice
• Other parties related to Human clinical trial practice

》Why you need to apply Human Clinical Trial Insurance？

The trend of protecting "trial subjects" is now being launched into laws worldwide(health insurance does not cover any damages caused by attending human clinical trials), hence, the human clinical trial executors need to transfer the risk to the insurance company.

》How to decide limit of liability ?

The Limit of Liability means the insurance company should be liable for an aggregate amount during the policy period. Generally, there are certain limits to the amount of liability per claim and for the aggregate amount during the policy period.

The insured can decide the limit of liability based on risk demand or take the insurance company's suggestion to choose the suitable amount of limit of liability.

》What is Self Insured Retention (SIR)？

When each has claim occurred, the insured should be liable and pay the Self-Insured Retention (SIR) amount first (this also applies towards handling costs and expenses). The amount that goes over the SIR but is within the limit of liability will be responsible by the insurance company.

》How long the insurance period is ?

The insurance period will be based on the period of human clinical trial.

》What is the claim basis？

The claim basis for Human Clinical Trial Insurance is Claims-Made basis.

Claims Made Form: The loss or accident should happen within the treatment period and the claims will be made to the insured either to the insured or the insurance company within the policy period.

》Territory/ Jurisdiction

Taiwan, ROC only.

》Certificate of Insurance

After the policy is written, the insured may apply for insurance certificates and make requests from superior organization or for specific needs in business development.

》How much is the Premium Rate ?

No fixed rate for specified products, there are five major factors may influence the premium rate.

• Nature of insured products
• The number of subjects
  
• The criteria of subjects
• The way of distributing insured products and how long the treatments last.
• Others include: Loss of records, Market variations, clinical trial performer or hospital professions.
  

》Calculation of Premium

• The insurance premium is calculated by the risk of the human clinical trials and various related risk conditions and the insurance premium should be paid when the policy goes into effect.
• There is a stipulation of a minimum premium for each policy.
  

》What is the Claim Procedure ?

If the test subject has Adverse Effects, please follow the procedure of "Adverse Effect Reporting System" ruled by DOH. Meanwhile, please notify us, V&C's colleague will assist you and work together with you for the best solution.

》What is the process for applying for Human Clinical Trial Insurance ?

Calling us or/and sending us your inquiries. One of V&C's colleague will contact you and work together with you for your best solution.