Clinical Trial Center

The Clinical Trial Center (CTC) supports Policlinico’s investigators in managing clinical trials by providing effective and efficient organizational strategies, including economic and financial aspects that typically fall outside the scope of a researcher’s expertise. The Center is composed of dedicated, highly qualified, and specialized personnel.

Clinical trials play a key role in driving innovation, offering new health and treatment opportunities to patients, and contributing to cost savings for the National Health Service (SSN).
In line with the mission of the hospital, the CTC serves as the point of contact for both commercial and academic sponsors, who recognize Policlinico as a center of excellence for the development of innovative drugs and the testing of new therapeutic strategies, with the goal of providing our patients with the best care available.

Thanks to an innovative organizational model similar to the "Clinical Operations" units of commercial sponsors, the CTC offers a comprehensive portfolio of clinical research services covering all types of interventional and non-interventional studies, in compliance with the highest national and international quality standards.

• Feasibility analysis: evaluation of the feasibility of a study proposed by an external sponsor, considering both scientific and statistical validity as well as resource allocation (human and financial), through pre-assessment meetings with the study team.

• Trial management: coordination of clinical trials through planning and supervision of activities involving dedicated personnel in the clinical units conducting the studies (e.g., study coordinators and research nurses) and in supporting departments (e.g., pharmacy, radiology, laboratories, etc.).

• Financial management: the CTC has specialized personnel responsible for financial reporting, invoicing, and revenue allocation for industry-sponsored trials.

• Project management: design (study protocol, milestones), planning (timelines), and oversight of studies sponsored by Policlinico, including cost evaluation.

• Study start-up: support in obtaining the necessary ethical and regulatory approvals for the initiation and conduct of single- or multi-center clinical trials sponsored by Policlinico.

• Pharmacovigilance: management of a pharmacovigilance system in accordance with applicable regulations to fulfill the responsibilities of the trial sponsor, including the development and implementation of a Risk Management Plan for Phase I studies.