Mexico

Mexico Clinical Trial Quote Request

Yes

n/a

n/a

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

Australia Clinical Trial Quote Request

No, but is typically preferred by EC

AUD 10M or AUD 20M depending on territory where study is taking place.

PLEASE CONFIRM WITH YOUR CRO for limit required

12 months but 72 months in respect of Western Australia and/or Queensland.

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Local CRO or Institution name (Contact Person Name, Address, Telephone Number and E-Mail Address)
• Local CRO GST (Goods and Services Tax) Number. ABN (Australian Business Number) is also sufficient

If Sponsor has a local entity to be listed without the Local CRO on policy, a Goods & Services Tax (GST) will be required for the local sponsor entity. If none available, there is a tax implication. The same trial in New Zealand can be added to this policy for additional premium. Please check with your CRO beforehand to advise if a shared policy is acceptable.