Clinical Trial Center

Tomino Carlo

The goals of the Drug Center (CdF) are to provide methodological and regulatory expertise for the conduct of clinical research, both by the San Raffaele Group and by outside companies.

These services range from the design and coordination of research projects to project management of studies;from analyisideidatie finalstudy reports to the development of regulatory dossiers (registration, pricing and reimbursement).

The CoF works in perfect harmony with the Clinical Trial Center, which operationally supports all phases of the design, management and conduct of clinical trials, with a view to providing a high-quality clinical research service.

The Clinical Trial Center (CTC) was established within the San Raffaele Group to support clinical research activities conducted in the areas of expertise.

The various departments have organized themselves independently, aware of the importance of having dedicated resources for this activity. The CTC harmonizes intra-departmental activities and thus aims to support clinical units in the preparation, conduct and completion of clinical studies, whether interventional or observational. The CTC has internal regulations regarding the functions and responsibilities of all members belonging to the Team and has developed all the necessary SOPs for carrying out its activities, prior to the initiation of studies, during their execution and at the conclusion of clinical research activities.

Gli obiettivi

Both the drug center and the clinical trial center need structural, logistical and human resource development with substantial investment. However, it is realistic to say that a strengthening of these facilities may reverberate with significantly positive effects on clinical research activities, with obvious benefits for researchers and especially for patients who may be increasingly involved with innovative products.
Nowmi the role of these structures (CdFs and CTCs) and is indispensable in the daily activities of an IRCCS (Scientific Research and Treatment Institute); recent regulatory provisions, now at the EU level (Regulation 536/2014 for clinical trials of medicines and Regulation 745/2017 for studies with medical devices) impose important choices and an increasingly widespread and precise organization.
To this end, new and larger spaces dedicated to these two booming units have been identified in the future health facility.


With the planned developments and the grafting of 3-4 specialized units, the CoF will be able to extend its current services by also going to offer expertise in Registration and Market Access.


Registration & Market Access

  • Support in the “price and reimbursement” process;
  • Support for early market access (Law 648/1996, compassionate use, L.94/98, import of drugs from abroad);
  • Definition and establishment of multidisciplinary scientific boards;
  • Support in registration processes (centralized, mutual and national; adaptivelicensing, conditionalapproval, etc.);
  • Development of P&R files;
  • MOCK negotiation.


Turning to the Clinical Trial Center, there is no doubt that the positive experiences to date (e.g., neurology, headache and cardiology) will need to be extended to all clinical areas, offering and collaborating at all times in clinical trials. In addition, the CTC will be the privileged and exclusive contact person to interface with product companies (pharmacies and medical devices) right from the feasibility stages, so that clinicians will be spared their involvement in technical and bureaucratic activities.

Standard Operating Procedures will be made transversal; Procedures will be developed for proper correlation with the Ethics Committee and the competent authority (AIUFA or Ministry of Health), as well as in relations with study-promoting companies and their specific figures (Monitor, Data Manager, etc.)

Again, in addition to the logistical aspects and specialized figures in the areas of expertise, it is realistic to think of 5-6 dedicated figures (data managers, trial nurses, and contact persons with regulatory capabilities).

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