Australia

Australia Clinical Trial Quote Request

No, but is typically preferred by EC

AUD 10M or AUD 20M depending on territory where study is taking place.

PLEASE CONFIRM WITH YOUR CRO for limit required

12 months but 72 months in respect of Western Australia and/or Queensland.

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Local CRO or Institution name (Contact Person Name, Address, Telephone Number and E-Mail Address)
• Local CRO GST (Goods and Services Tax) Number. ABN (Australian Business Number) is also sufficient

If Sponsor has a local entity to be listed without the Local CRO on policy, a Goods & Services Tax (GST) will be required for the local sponsor entity. If none available, there is a tax implication. The same trial in New Zealand can be added to this policy for additional premium. Please check with your CRO beforehand to advise if a shared policy is acceptable.

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