Romania

Clinical Trial Application	Romania Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	From 6.000 to 100.000 €/patient Up to 5.000.000 €/protocol (limits depend upon the carrier)
Tail Coverage	2 years after the damage has occurred
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Romanian • Site List in English, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code

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