Mexico

Mexico Clinical Trial Quote Request

Yes

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THE PROCESS IN MEXICO IS SLOW. PLEASE ALLOW UP TO TWO MONTHS FOR DOCUMENTS TO BE PROCESSED. Please provide all documentation outlined below otherwise the process is further delayed.

PLEASE PROVIDE THE FOLLOWING INFORMATION
• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English and Spanish
• Protocol Title in Spanish
• The following documents to be provided by the Sponsor:
(i) Copy ID of the legal representative of the Sponsor (this should be the same as the person completing the form)
(ii) Proof of address of the sponsor (not older than 3 months)
(iii) Document confirming the legal establishment of the sponsor --->
Legal representative details of the Sponsor in Mexico
Note the Legal Representative will be responsible for providing the following documents:
(i) Copy of the Memorandum of Association registered upon the Property & Commerce Public registry
(ii) Copy of the Fiscal Identification Schedule (RFC)
(iii) Copy of an Official Identification and Notary’s Testimony of the local CRO
(iv) Copy of a Domicile Voucher

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.