Saudi Arabia

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

Dominican Republic Clinical Trial Quote Request

Dominican Republic Due Diligence Form - Spanish (Persona Juridica)

Yes and No. Clinical Trial Insurance is not compulsory, however, it is made mandatory as part of the MoH submission.

n/a

n/a

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Spanish
• Legal Representative in Dominican Republic or Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address)
• No refund for policy cancellation

Due to strict Anti-Money Laundering laws, the Legal Representative (typically your local CRO) will be responsible for providing the following documents:
(i) Due Diligence Form, available in Spanish only (to be completed by US Sponsor and each named insured, including additional insureds)
(ii) Fiscal ID certificate
(iii) Mercantile Registry
(iv) ID of the person acting on behalf of the Legal Representative
(v) Certificate of final beneficiary

Process in the Dominican Republic is SLOW, so please allow for additional time - minimum 1 month before receipt of documentation after binding coverage