In Italy, to operate as a Contract Research Organization (CRO) you must meet the minimum requirements set out in Ministerial Decree November 15, 2011 available on the AIFA website at the following link:
http://www.agenziafarmaco.gov.it/it/content/decreto-ministeriale-15-novembre-2011
![](https://www.aicro.it/wp-content/uploads/2016/10/contract-research-org.jpg)