Italian Regulation Approval Process

In Italy, the conduct of clinical trials is subject to authorization by the Competent Authority Agenzia Italiana del Farmaco – AIFA and positive opinion by the Ethics Committee. The applicable regulation for clinical trial conduct is the Legislative Decree 24 June 2003, No. 211 transposing Directive 2001/20/EC concerning the implementation of GCP.

Clinical trial start-up time: 5 – 5.5 months.

Italian Pre-Market Requirements

All European investigations for devices, need to be prepared according to ISO 14155. It is also required by the Competent Authorities to complete Risk Analysis documentation in compliance with ISO 14971. In addition to staying compliant to these regulations, it is also required that all clinical trial agreements follow the AIFA Contract template found on the AIFA website. 

Investigators and Sites

Our Italian Investigators are well versed the necessary submissions and parallel submission process to the Ethics Committees and Competent Authority. Our site procedures include Italian CRAs are physicians, pharmacists, biologists or nurses, allowing us to exercise our relations with the investigators and produce quality of the data.