Dominican Republic

Dominican Republic

Dominican Republic

Dominican Republic

Clinical Trial Application

Dominican Republic Clinical Trial Quote Request

Dominican Republic Due Diligence Form - Spanish (Persona Juridica)

Mandated Coverage

Yes and No. Clinical Trial Insurance is not compulsory, however, it is made mandatory as part of the MoH submission.

Standard Limits

n/a

Tail Coverage

n/a

Data Required to Quote

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Spanish
• Legal Representative in Dominican Republic or Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address)
• No refund for policy cancellation

Due to strict Anti-Money Laundering laws, the Legal Representative (typically your local CRO) will be responsible for providing the following documents:
(i) Due Diligence Form, available in Spanish only (to be completed by US Sponsor and each named insured, including additional insureds)
(ii) Fiscal ID certificate
(iii) Mercantile Registry
(iv) ID of the person acting on behalf of the Legal Representative
(v) Certificate of final beneficiary

Process in the Dominican Republic is SLOW, so please allow for additional time - minimum 1 month before receipt of documentation after binding coverage

France

France

Clinical Trial Application

France Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes

Standard Limits

1.000.000 €/patient
6.000.000 €/protocol
10.000.000 €/year

Tail Coverage

10 years

Data Required to Quote

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in French
• Site List in English, 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.
• Local CRO or EU Representative details (Contact Person Name and Telephone Number). Will be referenced on the Policy declaration page and the Certificate
• Provide EudraCT Number for Drug studies or EUDAMED No. for Medical Device studies, if not already included in Protocol