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

Russia Clinical Trial Quote Request

Clinical Trials Quote Request

Yes

1 – in the case of death of patient, the claim payment in the specified amount is equally distributed between the Beneficiaries in proportion to their number:
2 000 000 RUR
2 – in case of deterioration of health (different degrees). Limits (3 disability groups):
group 1 : 1 500 000 RUR
group 2 : 1 000 000 RUR
group 3 : 500 000 RUR
3 – in case of deterioration of health not resulting in the assignment of a disability group, – not more than 300.000 RUR
The amounts of claim payments specified above may be increased on the basis of an effective legal decision

2 years

THE PROCESS IN RUSSIA IS SLOW. PLEASE ALLOW UP TO TWO MONTHS 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 Russian
• Sponsor/Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address) required to bind coverage

1. Provide copy of the MoH approval letter once coverage is bound and insurance documentation provided. MoH approval letter required in order for the carrier to issue individual patient policies
2. Please note that the individual patient policies are sent directly from the carrier to the CRO for distribution to the clinical sites
3. Sponsor will not receive copies of the completed individual policies as these are kept at the clinical site file with a copy given to the patient
4. On a quarterly basis, the CRO is to provide the Sponsor with a list of IICPs (these are the numbers generated and necessary to protect the patient's privacy).
5. Once provided to the carrier, the carrier will endorse the list of IICPs onto the Policy
Sponsor will receive a draft copy of the individual policy(ies). The original policy(ies) will only be issued once premium payment has been received and the MoH approval letter has been provided

- Sponsor must provide a wire confirmation once premium is paid
- No refund for policy cancellation