Brazil

Brazil

Brazil

Brazil

Clinical Trial Application

Brazil Clinical Trial Quote Request

Mandated Coverage

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.

Standard Limits

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

Tail Coverage

n/a

Data Required to Quote

• 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.

Poland

Poland

Clinical Trial Application

Poland Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes

Standard Limits

FOR DRUG STUDIES
2.000.000 € up to 50 patients
5.000.000 € more than 50 patients

FOR MEDICAL DEVICE STUDIES
50.000 € for up to 10 patients
100.000 € for 11 to 25 patients
200.000 € for 26 to 50 patients
400.000 € for 52 to 100 patients
500.000 € for more than 100 patients

FOR OTHER STUDIES
Clinical trials which are not regulated by local law
OPTION A
5.000.000 PLN/protocol
500.000 PLN/patient
OPTION B
10.000.000 PLN/protocol
1.000.000 PLN/patient

Tail Coverage

10 years maximum after the event causing the injury
3 years after the patient is aware of his problem

Data Required to Quote

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Polish

Only a Policy is issued for Poland