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CLINICAL TRIALS IN ITALY
The National Observatory on Clinical Trials (OsSC) manages the authorisation process of clinical trials (Phase I-IV) that are conducted in Italy and provides a real time picture of the clinical research progress in the country. It also acts as an interface for transferring information to the European EudraCT database.
It allows to submit applications for clinical trials and for substantial amendments to clinical trials already initiated, including all related documentation, at the same time to AIFA, as the competent authority, and to the coordinating ethics committee, as well as to all reference ethics committees for each trial.
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 (clinicaltrials.gov) 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.
It allows to submit applications for clinical trials and for substantial amendments to clinical trials already initiated, including all related documentation, at the same time to AIFA, as the competent authority, and to the coordinating ethics committee, as well as to all reference ethics committees for each trial.
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 (clinicaltrials.gov) 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.
CLINICAL DEVELOPMENT SOLUTIONS OVERVIEW
CLINICAL TRIALS IN ITALY
The National Observatory on Clinical Trials (OsSC) manages the authorisation process of clinical trials (Phase I-IV) that are conducted in Italy and provides a real time picture of the clinical research progress in the country. It also acts as an interface for transferring information to the European EudraCT database.
It allows to submit applications for clinical trials and for substantial amendments to clinical trials already initiated, including all related documentation, at the same time to AIFA, as the competent authority, and to the coordinating ethics committee, as well as to all reference ethics committees for each trial.
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 (clinicaltrials.gov) 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.
It allows to submit applications for clinical trials and for substantial amendments to clinical trials already initiated, including all related documentation, at the same time to AIFA, as the competent authority, and to the coordinating ethics committee, as well as to all reference ethics committees for each trial.
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 (clinicaltrials.gov) 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.
Therapeutic areas in Italy:
- Oncology
- Hematology
- Cardiovascular
- Metabolic
- Central nervous system (CNS)
- Dermatology
- Infectious diseases
- Respiratory diseases
- Pain
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI, Rome
INSTITUTO ORTOPEDICO RIZZOLI, Bologna
CENTRO CARDIOLOGICO MONZINO, Milan