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

Ukraine

Ukraine

Clinical Trial Application

Ukraine Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes

Standard Limits

Limit per protocol = 10.000 USD x number of patients

Tail Coverage

3 years

Data Required to Quote

The process is SLOW. Please allow additional time for processing. Typically up to 3 weeks

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Ukrainian
• Certificate of Incorporation of Sponsor (for new Sponsors in Ukraine only)
• Name and Title of Authorized Signatory who will countersign policy
• Name of document which gives the Signatory the authorization to countersign the policy. (i.e. Charter, Power of Attorney, Resolution by the Board of Directors)

- Ukraine requires payment and payment confirmation documentation PRIOR to release of certificate
- No refund for policy cancellation
- Original documents are not required to be delivered to the local CRO. Only require copy of the Certificate which is issued by the carrier once the premium has been received