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Saudi Arabia & Philippines

Saudi Arabia

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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

Philippines

Clinical Trial Application	Philippines Clinical Trial Quote Request
Mandated Coverage	Yes
Standard Limits	2M USD/protocol
Tail Coverage	1 year after the end of the study
Data Required to Quote	THE PROCESS TO ISSUE DOCUMENTS IS SLOW. PLEASE ALLOW 3-4 WEEKS TIME AS WE ARE NOT ABLE TO EXPEDITE DOCUMENTS • Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Name and contact details of the Local CRO (include full name, contact person, address, email, telephone number) • Copy of the CRO’s Certificate of Accreditation from FDA Philippines • Completed KYC Form (to be provided by Newfront for completion) - No refund for policy cancellation