Ukraine

Ukraine Clinical Trial Quote Request

Clinical Trials Quote Request

Yes

Limit per protocol = 10.000 USD x number of patients

3 years

The process is SLOW. Please allow additional time for processing. Typically up to 3 weeks

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Ukrainian
• Certificate of Incorporation of Sponsor (for new Sponsors in Ukraine only)
• Name and Title of Authorized Signatory who will countersign policy
• Name of document which gives the Signatory the authorization to countersign the policy. (i.e. Charter, Power of Attorney, Resolution by the Board of Directors)

- Ukraine requires payment and payment confirmation documentation PRIOR to release of certificate
- No refund for policy cancellation
- Original documents are not required to be delivered to the local CRO. Only require copy of the Certificate which is issued by the carrier once the premium has been received

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.

n/a

n/a

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