{"id":5049,"date":"2025-12-05T16:07:50","date_gmt":"2025-12-05T15:07:50","guid":{"rendered":"https:\/\/irccs.com\/divisioni-cliniche\/phase-i-clinical-unit\/"},"modified":"2026-03-26T14:59:17","modified_gmt":"2026-03-26T13:59:17","slug":"phase-i-clinical-unit","status":"publish","type":"medical-area","link":"https:\/\/irccs.com\/en\/divisioni-cliniche\/phase-i-clinical-unit\/","title":{"rendered":"Phase I Clinical Unit"},"content":{"rendered":"\n

<\/span>Description<\/h2>\n\n\n\n

The Phase I Clinical Unit is part of the Advanced Clinical Research and Innovation Directorate,<\/a> within the Scientific Directorate<\/a>, and works in close collaboration with the Health Management<\/a>, General Management, and all clinical units of the Institute.
The Unit plays a central role in advancing oncology research<\/a><\/strong>, contributing to the development of new drugs while ensuring clinical activities according to the principles of Good Clinical Practice (GCP) and comply with national and international regulations.<\/p>\n\n\n\n

Its mission is to provide patients with access to the most innovative cancer therapies<\/strong>, translating preclinical research findings into practical and safe treatments.<\/p>\n\n\n\n

Self-certified by AIFA <\/strong>in 2018 (code FI\/171), the Unit is organized according to national and international regulatory standards and has advanced technological and professional resources that enable it to conduct Phase I trials with high levels of safety, quality, and regulatory compliance.<\/strong><\/p>\n\n\n\n

The Phase 1 Clinical Unit<\/strong> includes 8 beds <\/strong>dedicated to patients involved in Phase I studies, distributed between the Day Hospital and the Oncology Inpatient Ward. The clinical activity is supported by the Phase I Laboratory Unit<\/strong> (code FI\/172), also AIFA self-certified as of 2018, which expertly handles biological samples and all analyses required for early-phase studies.<\/p>\n\n\n\n

<\/span>Responsibility<\/h2>\n\n\n\n

The Phase I Unit coordinates the entire clinical trials<\/strong> pathway<\/strong>, from assessing study feasibility to establishing operating procedures, staff training, and ongoing monitoring of patient safety and clinical outcomes.<\/p>\n\n\n\n

Main responsibilities include:<\/p>\n\n\n\n