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CRO for Clinical Trials in Italy

Italy is a European country with a long tradition of high quality clinical research and it is positioned within the top 5 countries in Europe with more clinical trials. By June 2021, the clinical trial database of the US ( showed a total of 15,428 clinical studies including the participation of Italian sites.

With a population of approximately 60 million inhabitants, Italy provides clinical trial sponsors with several prestigious clinical centers to conduct commercial and academic studies across multiple therapeutic areas. The largest Italian cities where clinical trials are conducted include Rome, Milan, and Naples. 

Sofpromed provides CRO services for biotech and pharma companies planning to include Italian hospitals in their clinical trials.

Our CRO services in Italy include:

  • Regulatory submissions and reporting
  • Ethics committee submissions and reporting
  • Clinical operations
  • Hospital selection and activation
  • Clinical site management
  • Clinical monitoring
  • Data management
  • Biostatistics and SAS statistical programming
  • Medical writing
  • Clinical study logistics (including biological samples, drugs, and supplies)

Among others, we are able to manage clinical trials in these therapeutic areas in Italy:

  • Oncology 
  • Hematology
  • Cardiovascular
  • Metabolic
  • Central nervous system (CNS)
  • Dermatology
  • Infectious diseases
  • Respiratory diseases
  • Pain