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

Georgia Clinical Trial Quote Request

Yes

Usually 2.000.000 €/protocol
No deductible

1 year

THE PROCESS IN GEORGIA IS SLOW. PLEASE ALLOW ONE MONTH FOR
DOCUMENTS TO BE PROCESSED. Please provide all documentation outlined below otherwise the process is further delayed.

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Georgian
• Site List in Georgian and English, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code
• Certificate of Incorporation of Sponsor
• CEO/Director details of Sponsor, together with Copy of Identification of CEO/Director of Sponsor (typically Drivers License or Passport)
• Sponsor to provide Local CRO contact details (Contact Person Name, Address, Telephone Number and E-Mail Address)

Due to the tightening of money laundering regulations, 25+% shareholders must be declared and the following provided:
1. For entities: Certificate of Incorporation and copy of Identification for all shareholders owning more than 25%
2. For individuals: copy of Identification for each shareholder owning more than 25%
3. Completed "Ultimate Beneficial Owners" (UBO) application. ABD to provide separately
4. Completed "Know Your Customer" (KYC) questionnaire. ABD to provide separately

NOTE: Georgia requires payment and wire payment confirmation details PRIOR to release of policy documentation

- No refund for policy cancellation
- Please note that Original Policy and Certificate documents are NOT a requirement in Georgia if there is no premium associated with the documents. If there is premium owed, then wet-inked originals are required by the carrier
- Sponsor to confirm with their local CRO and advise how many Originals are required for this study
- Sponsor first signs the Originals and then sends to the carrier
- Carrier sends countersigned wet-inked Originals directly to local CRO in Georgia once received from Sponsor