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

India Specific Clinical Trial Quote Request

Yes

From 1 to 5 Million USD in aggregate

6 months (up to 1 year available for an additional premium)

• Country-specific Application and Application must be printed and signed PRIOR to binding coverage
• Protocol and Informed Consent Form in English
• A local entity must be named as the Policyholder (Investigator or CRO)

- No refund for policy cancellation
- India requires payment to the carrier PRIOR to release of certificate

To bind coverage:
• provide Permanent Account Number (PAN) of the Local CRO. PAN number is a ten-digit alphanumeric number, issued in the form of a laminated card by the Income Tax Department
• provide Good and Services Tax (GST) number of the Local CRO

Please allow additional time for processing. Please allow at least one month before issuance of policy documents