Francesca de Nardis

Background

About Francesca de Nardis

I have acquired more than 10 years of experience in the clinical research field, managing all activities and aspects related to the start-up for both interventional and observational studies. Please see below a summary of my key responsibilities acquired in the clinical research field over the years- Clinical sites appraisal and selection, study set up, study budget planning- Submission of clinical trials and related amendments to the “National Monitoring Centre for Clinical Trials” database, follow-up with ethics committees and competent authority (AIFA) requests- Preparation, negotiation and execution of clinical study agreements through interaction with affiliate legal department and company intellectual property team, administration offices at public and private institutions- Responsible for preparation and review of clinical trials country/site documents (e.g. informed consent form, investigational drug labels etc.)- Management of payments process to Institutions and to Ethics Committees for clinical studies related activities- Ensuring timely update of procedures in matter of national and international regulation related to clinical studies- Management of all aspects related to the organization of investigators’ meetings- Compassionate Use program (Oncology/Hematology): full management of the whole procedure- Investigator Initiated Studies (Oncology/Hepatology): autonomous management of the entire process.