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

Belarus Clinical Trial Quote Request

Clinical Trials Quote Request

Yes. Only one state insurance carrier in Belarus.

20.000 €/patient
Limit per protocol = 20.000 x number of patients

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• Clinical Trial Quote Request
• LAST Protocol and Informed Consent Form in Russian
• Patient Information Sheet in Russian
• Investigator Brochure in Russian
• Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address)
• Sponsor Banking Details or Premium Wire Confirmation
• Three (3) years of claims history for harm caused or reimbursement of injured parties while carrying out clinical studies in Belarus. If no claims, please provide the following on your company letterhead, signed and dated: "We confirm that in the last three years (name of Sponsor) did not incur any claims related to clinical trials."
• Site List of clinical sites in Belarus, if the MoH approval letter is unavailable

Please allow additional time for processing. Typically up to 3 weeks for issuance of documents

Belarus requires payment and payment confirmation documentation PRIOR to release of certificate. No refund for policy cancellation. A letter of guarantee can be provided in order to obtain the necessary MoH approval.