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.

Netherlands

Netherlands

Clinical Trial Application

Netherlands Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes. www.ccmo.nl/en/insurance

Standard Limits

450.000 €/patient
3.500.000 €/protocol

Effective July 1, 2015, new limits required are:
650.000 €/patient
5.000.000 €/protocol

Tail Coverage

4 years from the end of patient treatment

Data Required to Quote

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

- There are TWO insurance requirements.
- Local admitted clinical trial insurance satisfies the G1 patient indemnity insurance requirement according to WMO
- The G2 is the liability insurance of Sponsor, which can be covered via a global product liability policy
- Therefore to satisfy G2, if the Sponsor has a Master Product Liability policy through Newfront, Newfront can provide a certificate