Georgia

Georgia

Georgia

Georgia

Clinical Trial Application

Georgia Clinical Trial Quote Request

Mandated Coverage

Yes

Standard Limits

Usually 2.000.000 €/protocol
No deductible

Tail Coverage

1 year

Data Required to Quote

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

Russian Federation

Russian Federation

Clinical Trial Application

Russia Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes

Standard Limits

1 – in the case of death of patient, the claim payment in the specified amount is equally distributed between the Beneficiaries in proportion to their number:
2 000 000 RUR
2 – in case of deterioration of health (different degrees). Limits (3 disability groups):
group 1 : 1 500 000 RUR
group 2 : 1 000 000 RUR
group 3 : 500 000 RUR
3 – in case of deterioration of health not resulting in the assignment of a disability group, – not more than 300.000 RUR
The amounts of claim payments specified above may be increased on the basis of an effective legal decision

Tail Coverage

2 years

Data Required to Quote

THE PROCESS IN RUSSIA 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
• Protocol Title in Russian
• Sponsor/Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address) required to bind coverage

1. Provide copy of the MoH approval letter once coverage is bound and insurance documentation provided. MoH approval letter required in order for the carrier to issue individual patient policies
2. Please note that the individual patient policies are sent directly from the carrier to the CRO for distribution to the clinical sites
3. Sponsor will not receive copies of the completed individual policies as these are kept at the clinical site file with a copy given to the patient
4. On a quarterly basis, the CRO is to provide the Sponsor with a list of IICPs (these are the numbers generated and necessary to protect the patient's privacy).
5. Once provided to the carrier, the carrier will endorse the list of IICPs onto the Policy
Sponsor will receive a draft copy of the individual policy(ies). The original policy(ies) will only be issued once premium payment has been received and the MoH approval letter has been provided

- Sponsor must provide a wire confirmation once premium is paid
- No refund for policy cancellation