This is an important time for clinical drug development in Italy following the implementation of the EU Clinical Trials Directive and revision of the Italian regulatory procedures
Chiltern International announces the opening of its new Italian office in Milan.
"With a population of almost 58 million, it is not surprising that Italy represents one of the major European countries for clinical trials," explained Mauro Germinario, clinical development leader and line manager for Chiltern Italy. "Every year around 600 new clinical trials are approved in Italy and a growing percentage are phase II and phase III trials. "Most of these are concentrated in the north of Italy, with Lombardia accounting for 30% of trials, Emilia-Romagna 11% of trials and Veneto 9% of trials".
This is an important time for clinical drug development in Italy following the implementation of the EU Clinical Trials Directive and revision of the Italian regulatory procedure for clinical trials, which incorporate decrees regulating all phase I trials as well as the participation of general practitioners and paediatricians in phase III and IV trials.
"Chiltern is ideally placed to help clients with their drug development objectives in Italy, adds Dr Germinario.
"In fact we were the first international organisation to be awarded both a CRO and sponsor password for the clinical trials database system in Italy, which is linked to the Eudract system".
Chiltern's office is located in central Milan at Corso Magenta 56, 20123, Milano.
Tel +39 02 365 344 98.
Fax +39 02 41 21 466.
