The Clinical Trial Center (CTC) of the OPBG Drug Development Center is a hub for:

1. The activities related to the start-up of clinical studies:

  • technical-scientific feasibility
  • qualification activities
  • contribution to the enhancement of the activities required by the specific study protocol

2. activities to support the conduct of clinical trials:

  • Clinical Research Coordinator Service
  •  Research Nurse Service

The centralization of these services in charge of the CTC allows to:

o standardize the approaches applied to each individual clinical study

o identify areas for improvement of the service and maintain the level of quality of each practice adequate and competitive

o maintain adequate control and compliance with the obligations in force for the specialized training of the personnel involved in the management and conduct of Clinical Research.

3. Phase 1 Unit activities, as certified by the Italian Regulatory Authority (AIFA), identified with code FI/53

4. Activities to support the development and conduct of all Non-Profit studies promoted by OPBG, with the support of the CTQT (Clinical Trial Quality Team)

The CTC coordinates the studies carried out in the Hospital, by managing most of the procedures in its headquarters, yet having a CRC (Clinical Research Coordinator) and Nurse referent person in each Department (and in the various OPBG offices).

The CTC makes use of task forces of experts for the implementation of highly specialized studies (e.g.: studies in Neonatology, Resuscitation, Transplantology).

This transversal approach of the Drug Development Center represents a Methodological Innovation in the field of pediatric clinical trials.