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Phase I Facilities

The San Matteo Phase I Unit has a dedicated facility for Phase I studies carried out in healthy volunteers and special populations.
Pharmaceutical labs for implementing formulation technology cooperate with the San Matteo Phase I Unit working group on the basis of preferential contracts.
The Unit meets the DPR 14/01/1997 qualifying criteria set by the DM 19/03/1998 for structural, plant and technology requirements and has specific SOPs for the management of all processes.
The Unit has an uninterruptible power supply (UPS) and a link to the generator of the Foundation IRCCS Policlinico San Matteo to compensate for any interruptions in the current network. The unit also has a dedicated area for the appropriate preservation of biological samples and experimental material.

Main features of the Phase I Unit:

  • A large pool of volunteers
  • 2 out patient ambulatories
  • 16 bed facility, 4 of which are fully monitored (wireless Escort Vision)
  • Dietary services for regular and special diets
  • State of the art medical equipment
  • Clinical pathology service
  • Pharmacy with controlled access, full temperature and humidity logging, regularly inspected by the Health Authorities
  • Continuous monitoring of EKG, SpO2 and blood pressure while volunteers are in bed or in the lounge area. Electronic data captured and transmitted to a central station with data storage
  • Temperature monitored refrigerator for drug storage, -80/-20 °C freezers for sample storage, biological safety cabinet, refrigerated centrifuges;
  • Nursery
  • Recreational room
  • State of the art computerized system for data analysis and report generation
  • Central archive with controlled access and full temperature and humidity logging
  • Other facilities within the Fondazione IRCCS Policlinico S. Matteo provide access to all types of equipment necessary to appropriately conduct all clinical studies.


  • Medical counseling
  • Surgical counseling
  • Specialist consultations required by the study protocol
  •  Medical emergency
  •  Psychological consultation
  •  Services related to clinical trials
  •  Pharmacy Services
  •  Central Laboratory Service
  •  Provision of regular meals
  •  Dietary Services
  •  Ethics Committee Services
  • Co-investigators/Study Physician

Research-experienced physicians are available to serve as co-investigators for Phase I trials. Areas of therapeutic expertise include, but are not limited to:
    Pain Therapy
    Infectious Disease

    Senior Research Nurse
    Research Nurses
    Healthcare operators

Data ultimo aggiornamento:  21/12/2011

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