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RESEARCH AND TECHNOLOGY DEVELOPMENT IN SARDINIA
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Clinical research unit

Researcher using the microscope
Fase 1 obtained the necessary logistic support from the G. Brotzu hospital in Cagliari. A Clinical research unit has been set up at the hospital, having the following characteristics.

Facility
The unit has a floor area of about 300 m2 on the 11th floor of the Brotzu Hospital, and meets the structural, utility and equipment requirements set out in the Presidential Decree of 14.01.1997 and criteria established for the certification of centres conducting drug clinical trials (Ministerial Decree 19.03.1998). The unit comprises:

1. Inpatient unit: 12 beds (divided into modules of 4 beds each) for standard studies and 6 dedicated beds for intensive studies. The facility will host:
- Phase I studies
- Pharmacokinetic and pharmacodynamic studies
- Proof of concept: special populations (such as the elderly, liver or kidney failure patients etc.), Phase IIA patients

2. Day clinic: day hospital facility. The facility will host:
- Day clinic studies
- Nutritional studies

The unit also has:
- access control and alarm system
- patient leisure area with satellite TV with pay TV channels, videogame console, computer with free Internet access, DVD players, book and video collection, newspapers and magazines and board games
- a medical examination/treatment room
- a sample collection room.

Volunteer database
The Clinical research unit of Fase 1 can draw on an adequate reserve of healthy volunteers and patients.

Medical emergencies
The facility has the appropriate set of emergency equipment:
- Full medical emergency equipment, including defibrillator, aspirator and emergency drug kit
- Compulsory training in resuscitation techniques delivered to all staff members, and repeated at least every 12 months
- 24-hour medical supervision
- The clinical unit is located in a hospital fully equipped to respond to any type of emergency (staff, techniques, diagnostic methods)

Clinical and pharmacodynamic measurements
The unit employs the following measuring techniques:
- Clinical examinations and specific scoring systems
- ECG, 24-hour Holter monitoring
- Cognitive functions
- Motor functions
- Biochemical markers.

Laboratories
The Clinical research unit can use the following lab facilities:
- Reference local clinical laboratory
- Central clinical laboratory
- Special clinical laboratory (immunology etc.).

Plasma sample storage
Plasma samples are stored with the utmost care.

The plasma sample storage system has the following features:
- Constantly controlled ambient temperature at 20-23°C
- Refrigerator (between 4°C and 8°C)
- Freezer (between -25°C and -18°C)
- Ultra low temperature freezer (between -80°C and -70°C)
- Constant ambient and refrigerator/freezer temperature monitoring, with periodic temperature recording
- Alarm system
- Security system.