Switzerland

Switzerland

Switzerland

Switzerland

Clinical Trial Application

Switzerland Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes

Standard Limits

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

Tail Coverage

20 years

Data Required to Quote

• 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

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