Georgia

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

Switzerland Clinical Trial Quote Request

Clinical Trials Quote Request

Yes

CHF 10,000,000
CHF 1,000,000 Per Patient

20 years

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in German, French or Italian
• Legal Representative Details of Sponsor (Contact Person Name, Address, Telephone Number and E-Mail Address) in Switzerland are are now required unless your CRO states this is NOT a requirement for your study.

- Switzerland has always required non-Swiss sponsored studies to have engaged a Swiss-based legal representative, but most Sponsors have not been required to comply in recent years.
- Due to current demands for the Legal Representative to be shown, please check with your CRO PRIOR to binding coverage.

- Swiss Ethics have released certificate/policy templates that must be followed. As part of this new format, Swiss Ethics require that the Insurers include in all policies the classification of the medicinal product i.e. Category A, B or C.
- Insurers do not hold descriptions for each class and cannot provide any advice on how a trial should be categorized.
- Categorization is considered to be a technical, medical and scientific decision, and if in any doubt over which category the trial should fall into, the Sponsor should seek advice from the Ethics Committees in such cases