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Kenya

Clinical Trial Application	Kenya Clinical Trial Quote Request Clinicals Trial Quote Request
Mandated Coverage	Yes
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. Please allow at least 3-4 weeks before receipt of documentation • Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Local CRO/Legal Representative details (Contact Person Full Name, Address, Telephone Number, E-Mail Address). • Provide Legal Representative Registration documents and Kenyan Revenue Authority PIN certificate - No refund for policy cancellation

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