Clinical Trials Center

It is a simple unit under the Scientific Directorate. It provides cross-cutting support to the main Clinical Departments involved in both observational and interventional clinical studies, with a particular focus on pharmacological clinical trials in PHASE I/II/III in the following disease areas: 

• Breast cancers 
• Gastrointestinal cancers (esophagus, stomach, small and large intestine) 
• Pancreatic and biliary tract cancers 
• Thoracic cancers 
• Neuroendocrine tumors 
• Genitourinary cancers 
• Melanoma and other skin cancers 
• Head and neck tumors 
• Sarcomas 
• Hematologic malignancies 
• Gynecological cancers 
• Hepato-gastro-pancreatic cancers and liver transplantation 
• Pediatric cancers 
• Hereditary digestive system cancers 

Within the Unit, Clinical Study Coordinators (SCs) operate according to Standard Operating Procedures (SOPs). The Clinical Trials Center is composed of a core team of SCs with specific expertise, working under the coordination of the Unit Lead, specifically: 

• SCs dedicated to Clinical Departments, supporting clinical trials for specific diseases 
• Cross-functional SCs, particularly focused on non-profit clinical trials sponsored by the Institute 
• Cross-functional SCs supporting prestudy activities and budget development 

Thanks to the training and experience of the staff, researchers can be supported in the following activities: 

• Feasibility analysis of a clinical study and identification of the required expertise and services for proper execution 
• Support in drafting clinical protocols within research project frameworks 
• Start-up activities for single-center and multi-center studies 
• Study coordination, including: 
• Management of the clinical trial and data collection in compliance with Good Clinical Practice (GCP) and protocol requirements 
• Communication with sponsors (Monitors, Pharmacovigilance, CROs, Auditors) 
• Maintenance of the Investigator’s Folder 
• Support in the management of investigational drugs and assignment via IVRS systems 
• Patient scheduling and support in biological sample handling 
• Coordination of satellite centers in multicenter studies 
• Support in coordinating the study team (physicians, nurses, pharmacists, laboratory staff, ethics committee) 
• Design and management of the case report form (CRF), both paper and electronic 
• Reporting and newsletters 
• Selection, coordination, and supervision of activities potentially delegated to external CROs (Clinical Research Organizations) for NON-PROFIT studies 
• Management of administrative procedures for requesting compassionate use drugs 
• Support in budget definition and in the financial reporting process 

The Clinical Trials Center also plays an important role in maintaining the quality management system to ensure that study management processes are always compliant with GCP and current regulations, specifically: 

• Staff selection, onboarding, and training 
• Drafting and revision of SOPs 
• Coordination of cross-functional processes (e.g., self-certification for conducting PHASE I studies) 
• Coordination of the Clinical Trials Quality Team for non-profit studies 
• Process improvement initiatives (e.g., development with ICT of dedicated modules for managing clinical trials within the electronic medical record / implementation of the clinical trials platform)