Russian Federation

Russian Federation

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

Belarus

Belarus

Clinical Trial Application

Belarus Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes. Only one state insurance carrier in Belarus.

Standard Limits

20.000 €/patient
Limit per protocol = 20.000 x number of patients

Tail Coverage

n/a

Data Required to Quote

• Clinical Trial Quote Request
• LAST Protocol and Informed Consent Form in Russian
• Patient Information Sheet in Russian
• Investigator Brochure in Russian
• Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address)
• Sponsor Banking Details or Premium Wire Confirmation
• Three (3) years of claims history for harm caused or reimbursement of injured parties while carrying out clinical studies in Belarus. If no claims, please provide the following on your company letterhead, signed and dated: "We confirm that in the last three years (name of Sponsor) did not incur any claims related to clinical trials."
• Site List of clinical sites in Belarus, if the MoH approval letter is unavailable

Please allow additional time for processing. Typically up to 3 weeks for issuance of documents

Belarus requires payment and payment confirmation documentation PRIOR to release of certificate. No refund for policy cancellation. A letter of guarantee can be provided in order to obtain the necessary MoH approval.