Germany

Germany Clinical Trial Quote Request

Germany Business Travel Accident Application (OPTIONAL)

Clinical Trials Quote Request

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Yes - Local Policy Required

500.000 €/patient is typically mandatory
5 to 50.000.000 €/protocol (varies and is dependent upon review by the carrier and often driven at the request of the Ethics Committee)

5 years for the damage
10 years for the claim

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in German
• Provide EudraCT Number for Drug studies or EUDAMED No. for Medical Device studies, if not already included in Protocol

- When the trial is completed, both the number of treated and the number of screened patients are required by the carrier and this may result in additional premium

If you need to obtain a Germany Business Travel Accident policy, please note the process is VERY slow to obtain the certificate and policies so please allow plenty of time. In addition to the completed Travel Accident application, please provide the number of trips each subject will make.

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