Saudi Arabia

Saudi Arabia Clinical Trial Quote Request

Clinical Trials Quote Request

Yes

SFDA Regulations & Requirements for Conducting Clinical Trials on Drugs specifies Subjects Insurance is required for Phase II & III, but not Phase IV studies. There is no mention about Phase 0 or 1 studies, so it is unclear if these studies are permitted in Saudi Arabia or not. Please confirm with your CRO or Ethics Committee.

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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 the intermediaries involved. Submission should be made to Newfront at least one month before documents are required.

Please note that only a Policy is provided. Certificates are not provided for Saudi Arabia.

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Local CRO/Legal Representative details (Contact Person Name, Address, Telephone Number and E-Mail Address)

The Local CRO/Legal Representative must provide the following documents:
• Letter of Appointment issued by the Local CRO/Legal Representative in Saudi Arabia addressed to Saudi broker
• Commercial Registration (CR) with the Saudi Chamber of Commerce
• National Address Registration (NAR) by logging into https://address.gov.sa/sa/ar/
to register the national address in Saudi Arabia
• VAT Certificate
• Complete a "Know Your Client (KYC)" application form - to be provided separately by Newfront
• Copy of Passport/ID of Local CRO/Legal Representative

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

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• 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.