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.

n/a

No

Provided by US Master Product Liability policy.

(If your study is being conducted in Quebec, please check with your CRO to confirm coverage under the US Master Product Liability policy is acceptable)

n/a

Please submit an email request to our certificate team requesting a certificate at: techcertrequest@newfront.com and CC your Newfront Team.

Include the following in your email:
o Include in your email the following: RE: Protocol #, Country
o Attach the Protocol and Informed Consent Form (ICF) documents, if not already provided to Newfront

o If your CRO is requiring a local policy in Canada, please submit a Clinical Trial Liability Quote request and provide the estimated patient split per province for tax calculations.