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.

Switzerland

Switzerland

Clinical Trial Application

Switzerland Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes

Standard Limits

CHF 10,000,000
CHF 1,000,000 Per Patient

Tail Coverage

20 years

Data Required to Quote

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in German, French or Italian
• Legal Representative Details of Sponsor (Contact Person Name, Address, Telephone Number and E-Mail Address) in Switzerland are are now required unless your CRO states this is NOT a requirement for your study.

- Switzerland has always required non-Swiss sponsored studies to have engaged a Swiss-based legal representative, but most Sponsors have not been required to comply in recent years.
- Due to current demands for the Legal Representative to be shown, please check with your CRO PRIOR to binding coverage.

- Swiss Ethics have released certificate/policy templates that must be followed. As part of this new format, Swiss Ethics require that the Insurers include in all policies the classification of the medicinal product i.e. Category A, B or C.
- Insurers do not hold descriptions for each class and cannot provide any advice on how a trial should be categorized.
- Categorization is considered to be a technical, medical and scientific decision, and if in any doubt over which category the trial should fall into, the Sponsor should seek advice from the Ethics Committees in such cases