Poland

Poland

Poland

Poland

Clinical Trial Application

Poland Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes

Standard Limits

FOR DRUG STUDIES
2.000.000 € up to 50 patients
5.000.000 € more than 50 patients

FOR MEDICAL DEVICE STUDIES
50.000 € for up to 10 patients
100.000 € for 11 to 25 patients
200.000 € for 26 to 50 patients
400.000 € for 52 to 100 patients
500.000 € for more than 100 patients

FOR OTHER STUDIES
Clinical trials which are not regulated by local law
OPTION A
5.000.000 PLN/protocol
500.000 PLN/patient
OPTION B
10.000.000 PLN/protocol
1.000.000 PLN/patient

Tail Coverage

10 years maximum after the event causing the injury
3 years after the patient is aware of his problem

Data Required to Quote

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Polish

Only a Policy is issued for Poland

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