Clinical Trial Submissions to Research Ethics Committees and IRB in Italy

Sofpromed provides research ethics committee / Institutional Review Board (IRB) submission services for clinical trials to be conducted in Italy. These services include:

• Creation and review of documents required for ethics committee submission (protocol, informed consent form, etc.) in Italy
• Collection of site documents needed for ethics submission (Principal Investigator’s CV, GCP, local signatures, etc.)
• Adaptation and translation of documents according to local Italian requirements
• Preparation and review of submission package
• Completion of clinical trial application form
• Clinical trial application submission to research ethics committees associated to Italian hospitals
• Responses to clarification requests and questions raised by evaluators
• Phase I-IV clinical trials with drugs or medical devices in all therapeutic areas (oncology, cardiovascular, metabolic, central nervous system, dermatology, infectious and respiratory diseases, among others)

Please contact us if you need help to submit a clinical trial application to ethics committees located in Italy.