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Poland

Clinical Trial Application	Poland Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	FOR DRUG STUDIES 2.000.000 € up to 50 patients 5.000.000 € more than 50 patients FOR MEDICAL DEVICE STUDIES 50.000 € for up to 10 patients 100.000 € for 11 to 25 patients 200.000 € for 26 to 50 patients 400.000 € for 52 to 100 patients 500.000 € for more than 100 patients FOR OTHER STUDIES Clinical trials which are not regulated by local law OPTION A 5.000.000 PLN/protocol 500.000 PLN/patient OPTION B 10.000.000 PLN/protocol 1.000.000 PLN/patient
Tail Coverage	10 years maximum after the event causing the injury 3 years after the patient is aware of his problem
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Polish Only a Policy is issued for Poland

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