Italy

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.

Nigeria Clinical Trial Quote Request

Clinical Trials Quote Request

Yes. It is recommended that Sponsor use an experienced or local CRO in Nigeria

n/a

n/a

Process is SLOW in Nigeria. Please allow for additional time. Submission should be made at least one month before documents are required


• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Local CRO details (Contact Person Name, Address, Telephone Number and E-mail Address)
• Completed, signed and dated Clinical Trial Proposal form (To be provided separately)
• Provide completed Anti-Money Laundering document which is required (To be provided separately)

- Regulatory Approval (RA) from the National Agency for Food & Drugs Administration and Control (NAFDAC), which can be provided after release of the policy documents, but is absolutely required unless the Sponsor does not have approval at the time of submission
- Nigeria requires a local quotation so the premium will be subject to change by the local Nigerian office
- Nigeria is a cash before cover country, which means Policy documents only released after premium payment received by the carrier; Sponsor pays the Carrier directly once invoice is provided and Carrier will confirm receipt of funds
- No refunds for policy cancellation