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Saudi Arabia

Saudi Arabia

Saudi Arabia

Saudi Arabia

Clinical Trial Application

Saudi Arabia Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage


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.

Standard Limits

n/a

Tail Coverage

n/a

Data Required to Quote

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

Turkey

Turkey

Clinical Trial Application

Turkey Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes

Standard Limits

€200,000 per patient
€2,000,000 per protocol

Tail Coverage

3 years increasing to 5 years for trials involving children and/or recombinant biologics/gene therapy, radiopharmaceutical IMPs

Data Required to Quote

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Turkish
• Local CRO details (Contact Person Name, Address, Telephone Number and E-mail Address)

- Carrier sends signed policy documents directly to the CRO - no signatures from Sponsor required
- Only a Policy is issued in Turkey