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

Clinical Trial Application	Pakistan Clinical Trial Quote Request
Mandated Coverage	Yes
Standard Limits	n/a
Tail Coverage	n/a
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Local CRO/Legal Representative details (Contact Person Name, Address, Telephone • Number and E-Mail Address), Tax Number and Sales Tax Number The Legal Representative is responsible for providing the following: • Tax number and sales tax number • Board resolution for insurance purposes • List of members/directors • Identity document of the person authorized to deal with the insurance carrier - Pakistan requires payment and wire payment confirmation PRIOR to release of documentation - Sponsor pays the carrier directly once invoice is provided - No refund for policy cancellation Quote process is VERY slow in Pakistan due to fronting and reinsurance carriers. Submission should be made to Newfront at least 45 days before documents are required.