The office, which is fully operational and already overseeing the act6ivities of clinical research staff, will manage operations for studies throughout the country as well as in Switzerland’s neighbouring Ticino canton and Malta.
PRA has operated in Italy, Europe’s fourth largest pharmaceutical market, since 2003 via a network of home-based staff, competiting against other international contract research organisations (CROs) like Icon, PPD, Charles River Laboratories and Covance.
Lucia Dolfi, PRA’s director of operations in Italy, told Outsourcing-pharma about the new office, citing rising contract research spending in the country as one of the key motivations for setting it up.
“Pharma companies in Italy are focusing internal efforts on core research, pipeline development, product management and marketing. As they recognize the benefits of outsourcing clinical research efforts, the proportion of budgets being used for CRO contracts is on the rise.”
Dolfi added that visibility is key in the highly competitive Italian clinical research sector, explaining that although 500 clinical studies are registered with the Ministry of Health (MoH) each year, at present, only 30 pre cent are managed by CROs.
Italian population benefits for CROs
Although the size of Italy’s drug market and cnetral European location undoubtedly make it a prime location for contract research, the country offers a number of other as a research distination according to Dolfi.
She explaimed that while the overall popultions is stable “the ratio of those over 65 years of age has already reached 20 per cent and is set to rise still further with a corresponding increase in chronic and long term medical conditions.
“The target population for new medicines in future therapeutic areas will often be the elderly then clinical trials will need to reflect this important part of the population. Thus, the profile of Italy’s population makes the country an ideal location for clinical trials in this in pathologies affecting mainly this target population.”
Dolfi added that the “ electronic Data Base (OsSC) implemented by [the] MoH is recognized among the member states as one of the most valuable electronic database for clinical trials in EU.”