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	Philippines Clinical Trial Quote Request
Mandated Coverage	Yes
Standard Limits	2M USD/protocol
Tail Coverage	1 year after the end of the study
Data Required to Quote	THE PROCESS TO ISSUE DOCUMENTS IS SLOW. PLEASE ALLOW 3-4 WEEKS TIME AS WE ARE NOT ABLE TO EXPEDITE DOCUMENTS • Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Name and contact details of the Local CRO (include full name, contact person, address, email, telephone number) • Copy of the CRO’s Certificate of Accreditation from FDA Philippines • Completed KYC Form (to be provided by Newfront for completion) - No refund for policy cancellation