Italy

Italy Clinical Trial Quote Request

Clinical Trials Quote Request

Yes

For Medical Device studies limits are:
1.000.0000 €/patient
2.5 to 10.000.000 €/protocol
depending upon the size of the trial

For Drug Studies limits will depend on the number of patients :
5.000.000 €/protocol up to 50 patients
7.500.000 €/protocol from 51 to 200 patients
10.000.000 €/protocol for more than 200 patients

For Medical Device Studies:
2 years (up to 5 years potentially available)

For Drug Studies:
=> Successor liability: The Damage (bodily injury) must occur within 24 months after the end of the study
=> Extended reporting period: A Claim must be made by a patient within 36 months after the end of the study

If the study involves gene therapy, cellular therapy, radio-pharmaceuticals or children, carriers are required to issue policies with tail coverage of at least 10 years. For the latter i.e. children, carriers issue 10 years irrespective if the study also involves adults

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Italian
• Site List is preferable in Italian, but English is acceptable, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code. This information is for the carrier files only. Will not be listed on the policy documents.

South Korea Clinical Trial Quote Request

Yes

n/a

1 year

THE PROCESS TO ISSUE DOCUMENTS IS SLOW. PLEASE ALLOW ENOUGH TIME AS WE ARE NOT ABLE TO EXPEDITE DOCUMENTS. It is very SLOW due to all of the intermediaries involved. Please allow for additional time - a minimum of 2 months before receipt of documentation


• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Local CRO/Legal Representative details (Contact Person Full Name, Address, Telephone Number, E-Mail Address), Local company Code/Registration CRO provides upon request

- Please note that the Local CRO/Legal Representative is the Policyholder. All insurance documents must be first issued to the Local CRO directly for review and acceptance before release to the Sponsor
- A separate pre-filled application will be provided for dating/signing to the Legal Representative in South Korea upon receipt of premium payment
- Premium payment and confirmation must be made PRIOR to receipt of policy
- Separate Fee for South Korea broker intermediary
- South Korea only requires a Policy; a Certificate is only provided upon request
- No refund for policy cancellation