Nigeria

Nigeria

Nigeria

Nigeria

Clinical Trial Application

Nigeria Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

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

Standard Limits

n/a

Tail Coverage

n/a

Data Required to Quote

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

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