Switzerland

Switzerland Clinical Trial Quote Request

Clinical Trials Quote Request

Yes

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

20 years

• 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

Italy Clinical Trial Quote Request

Clinical Trials Quote Request

Yes

For Medical Device studies limits are:
1.000.0000 €/patient
2.5 to 10.000.000 €/protocol
depending upon the size of the trial

For Drug Studies limits will depend on the number of patients :
5.000.000 €/protocol up to 50 patients
7.500.000 €/protocol from 51 to 200 patients
10.000.000 €/protocol for more than 200 patients

For Medical Device Studies:
2 years (up to 5 years potentially available)

For Drug Studies:
=> Successor liability: The Damage (bodily injury) must occur within 24 months after the end of the study
=> Extended reporting period: A Claim must be made by a patient within 36 months after the end of the study

If the study involves gene therapy, cellular therapy, radio-pharmaceuticals or children, carriers are required to issue policies with tail coverage of at least 10 years. For the latter i.e. children, carriers issue 10 years irrespective if the study also involves adults

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Italian
• Site List is preferable in Italian, but English is acceptable, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code. This information is for the carrier files only. Will not be listed on the policy documents.