Brazil

Brazil Clinical Trial Quote Request

Yes


Please confirm with CRO if your study requires coverage for Pregnant partners and unborn child before making a submission in this portal. If this is required, your CRO will need to obtain coverage on your behalf.

Between 1.000.000 and 5.000.000 USD for the whole duration of the protocol

n/a

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Portuguese
• Brazilian Tax ID (CNPJ number)
• Legal Representative in Brazil or Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address)


No refund for policy cancellation

PLEASE READ:
In addition to Sponsor binding approval, the Local Broker will issue the local quotation to the Brazilian CRO/Entity for confirmation of binding. Sponsor to follow-up with CRO to confirm binding and relay back to ABD.
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 a minimum 2 months before receipt of documentation.
Brazil can take 7-10 days to receive quote and about 4-6 weeks to receive the documentation.
Please allocate this additional time into your submission process. Submission should be made to ABD at least one month before documents are required.

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.