About us

CT/Clinical Trial Center is a center of excellence created to design and perform quality pediatric clinical trials. It promotes excellence of clinical trials in pediatrics and provides researchers with the means needed for high quality clinical trials.
CT/Clinical Trials Center was founded in 2010 as an Operative Unit of the University Department of Pediatrics, becoming soon a reference point for clinical trials. It is an integral part of a highly specialized pediatric Polyclinic and a Research Hospital, with pathways organized according to pathologies, personalized therapies, services for the patient and advanced technologies for high-level healthcare and clinical research.

The CT avails itself of a multidisciplinary team of professionals with different expetises:

The CT manages over 40 clinical trials in several specialized therapeutic areas:

  • Allergology
  • Cardiology
  • Dermatology 
  • Endocrinology
  • Cystic Fibrosis
  • Gastroenterology and Hepatology
  • Immunoinfectivology
  • Rare Diseases
  • Metabolic Diseases
  • Muscular Diseases
  • Neonatology
  • Nephrology
  • Neurology 
  • Neuropsychiatry
  • Pneumology
  • Rheumatology
  • Urology
  • Vaccines

For more information and for better understand why participate in a clinical trial, please visit the section information for patients.

CT/Clinical Trial Center is a facility fully dedicated to the development and management of clinical trials in children.
For this purpose, it performs clinical, scientific, management and training activities.

Clinical and scientific activities

  • New clinical trial design
  • Clinical trial protocol revision
  • Studies feasibility and selection of national/international centers and investigators
  • Consultancy on regulatory activities
  • Management of phase I-II-III-IV clinical trials  
    • Screening
    • Informed consent acquisition
    • Randomization
    • Drug administration
    • Collection, handling and shipment of biological samples
    • Specialized consultancies
    • Diagnostic tests through the Hospital services
    • Surveillance and reporting of Serious Adverse Events (SAE) and non-serious adverse events
    • Management of Pharmacokinetic study procedures
    • Data entry and Case Report Forms (CRF) completion
  • Clinical trial analysis and reporting 


Study Management

  • Ethics Committee/ IRB document submission
  • Management and financial reporting for sponsors and investigators
  • Trial file management and archiving 

Training

CT/Clinical Trials Center is devoted to spreading the culture of clinical research in pediatrics by providing all-round educational activities

  • Good Clinical Practices (GCPs) training courses
  • Research methodology in pediatric clinical trials, ethics, and regulatory aspects of clinical research in pediatrics

Training activities are divided into two levels:

  • Basic training: taught lessons and clinical trial simulation 
  • Advanced training: the CT/Clinical Trial Center is among the training centers of the International Master’s Degree in Pediatric Medicines Research of the University of Tor Vergata.

CT/Clinical Trials Center is located on the Salviati building of the Bambino Gesù Children’s Hospital (the Gianicolo premises) within The University Department of Pediatrics. 

The CT facilities are dedicated to the management of all clinical trials of the Bambino Gesù Children’s Hospital:

  • Inpatient rooms
  • Day Hospital and outpatient rooms
  • One room dedicated to investigational drug management
  • Waiting room
  • Meeting room for monitoring visits with CRAs (Clinical Research Associates) and meetings with sponsors
  • Physicians’ Office
  • Research nurses’ office
  • Healthcare devices and diagnostic tools (ECG, scales, multi-parameter monitors, emergency medical devices)
  • Study document archiving
  • Clinical trial laboratory for proper preparation and storage of biological samples, fully equipped with refrigerators (+4° C) and freezers (-70° C and -20° C) with controlled temperature, laminar flow cabinet and refrigerated centrifuge

The CT has access to the Bambino Gesù facilities, including:

  • Central Pharmacy Unit with rooms dedicated to investigational drugs, fully equipped with cabinets and refrigerators with controlled temperature
  • Digital conventional radiology
  • Computerized Tomography
  • Magnetic Resonance Imaging
  • Color Doppler Ultrasound
  • Echography
  • ISO 9001 quality accredited clinical-chemical laboratory Unit
  • Clinical-chemical analyses unit, organized according to TLA-Total Lab Automation system
  • Proteomics (MALDI-ToF and LC-MS/MS) for protein and non-protein molecular biomarkers identification and new proteins sequencing  
  • Molecular and genetic diagnostics
  • Advanced Immunological and microbiological diagnostics
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