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Ghana

Ghana

Ghana

Ghana

Clinical Trial Application

Ghana Clinical Trial Quote Request

Clinicals Trial Quote Request

Mandated Coverage

Yes. However, some Ethics Committees may accept evidence of your company's Master Product Liability/Clinical Trials policy. We recommend providing this evidence before securing a quote for local admitted clinical trials coverage in Ghana.

Standard Limits

n/a

Tail Coverage

n/a

Data Required to Quote

THE PROCESS IN GHANA 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
• Local CRO/Legal Representative details (Contact Person Name, Address, Telephone Number and E-Mail Address)
• Complete a "Know Your Client" (KYC) application form. ABD to provide separately

Premium payment directly to carrier is due in advance of release of policy documents

Saudi Arabia

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