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

Netherlands Clinical Trial Quote Request

Clinical Trials Quote Request

Yes. www.ccmo.nl/en/insurance

450.000 €/patient
3.500.000 €/protocol

Effective July 1, 2015, new limits required are:
650.000 €/patient
5.000.000 €/protocol

4 years from the end of patient treatment

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Dutch

- There are TWO insurance requirements.
- Local admitted clinical trial insurance satisfies the G1 patient indemnity insurance requirement according to WMO
- The G2 is the liability insurance of Sponsor, which can be covered via a global product liability policy
- Therefore to satisfy G2, if the Sponsor has a Master Product Liability policy through Newfront, Newfront can provide a certificate