Clinical Trial Submissions to Research Ethics Committees and IRB

Sofpromed provides research ethics committee / Institutional Review Board (IRB) submission services for clinical trials to be conducted in the main clinical research markets, such as North America, United Kingdom, Europe, and Asia-Pacific. These services include:

• Creation and review of documents required for ethics committee submission (protocol, informed consent form, etc.)
• Collection of site documents needed for ethics submission (Principal Investigator’s CV, GCP, local signatures, etc.)
• Adaptation and translation of documents according to local requirements
• Preparation and review of submission package
• Completion of clinical trial application form
• Clinical trial application submission to the research ethics committee including countries such as the United Kingdom, Australia, Spain, France, Germany, Italy, Poland, Czech Republic, Slovakia, Greece, and Georgia (other countries upon request)
• Responses to clarification requests and questions raised by the research ethics committee
• 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. If the country you are considering is not listed above, please send us a request.