CRC

 A facility designed for clinical research

The Clinical Research Centre is the CAST unit dedicated exclusively to studies in human subjects. Healthy volunteers and patients are received in spaces built around the requirements of clinical trials: dedicated rooms, controlled handling of the investigational medicinal product, documented procedures and trained staff

 The facility

● 4 inpatient rooms, 8 beds

● 2 of the beds are equipped with centralised multiparameter monitoring

● 2 outpatient rooms for screening visits, enrolment and clinical assessments

● Laboratory for the collection, processing and storage of biological samples

● Dedicated pharmacy service for the management of the investigational medicinal product, with a dedicated pharmacist, an access-controlled room and temperature-monitored storage

● Archive for the retention of study documentation for the periods required by law

Equipment

Monitoring and clinical assessment — centralised multiparameter monitoring, electrocardiograph, blood pressure monitors, anthropometric instruments.

Administration and emergency management — defibrillators, suction units, emergency trolley, infusion pumps.

Sample processing and storage — centrifuges, laminar flow hood, freezers and refrigerators with continuous temperature monitoring.

Storage of the investigational medicinal product — dedicated refrigerators and cabinets with temperature recording and alarm.

All equipment undergoes preventive maintenance at defined intervals, in accordance with the quality management system. For additional diagnostic needs, the CRC operates through agreements with services outside the facility.

Research activity

In 2025 the CRC conducted more than 35 international multicentre randomised controlled trials.

Sponsored registrational trials mainly concerned:

● neurological diseases

● dermatological diseases

● diabetes mellitus, obesity and related cardiovascular and renal complications

Alongside these, the Centre conducts investigator-initiated studies on diabetes and the pathophysiology of cardiovascular disease, neurodegenerative diseases and cognitive impairment.

Quality and compliance

The CRC conducts phase II, III and IV clinical trials. All studies are conducted in accordance with Good Clinical Practice (ICH-GCP E6), Regulation (EU) 536/2014 and the national legislation in force, following a favourable opinion from the competent Ethics Committee and in compliance with the standard operating procedures of the Centre and of the Sponsor.

The Centre operates within the quality management system: controlled procedures, documented GCP training, traceability of the chain of custody of the investigational medicinal product and of biological samples, management of deviations and corrective actions. The CRC is available for audits and inspections by Sponsors and Competent Authorities.