CT/Clinical Trial Center is a reference point for the conduction of profit clinical trials of the Bambino Gesù Children’s Hospital.
The CT ensures the organizational and administrative support to Sponsors for every phase of the trial, from pre-study visits to close-out visits, in full compliance and in accordance with Good Clinical Practices (GCPs) guidelines. Also, it avails itself of qualified personnel for the trial conduction (pediatricians, methodologists, research nurses, data managers).
The CT implements and ensures compliance with Standard Operating Procedures (SOPs) for quality control.
Pharmaceutical companies that wish to collaborate with the CT/Clinical Trial Center avail themselves of an extensive network of experts and benefit from established relationships that our professionals and investigators have established with national and international clinical research societies.
For clinical trials involving primary care pediatricians, CTC avails itself of the Italian Pedianet Network.
Activities for Sponsors
- Document collection in view of the Study Initiation Visit (SIV): CVs, Financial disclosure forms, GCP training certificates, laboratory quality certificates etc
- Collection and archiving of monitoring visit reports and any correction action
- Document management and archiving in compliance with applicable laws
- Phase I-II-III-IV precedure management (screening, randomization, drug dispensation, biological samples processing and shipment, adverse event notification)
- Pharmacokinetic (PK) studies management
- Case Report Form (CRF) completion
- Support for inspections and audits performed by regulatory institutions and correction of deviations
- Access to Hospital facilities needed for the conduction of the trial (MRI, ECG, CAT, etc)
- Analysis and reporting of clinical trials, training on GCPs, methodology of research in pediatrics, ethics and regulatory aspects of clinical trial in pediatrics.
Specialized Therapeutic Areas of the Bambino Gesù Children’s Hospital:
- Gastroenterology and Hepatology
- Endocrinology and Diabetology
- Clinical Immunology and Allergology
- Cardiac Diseases
- Rare Diseases
- General and Specialized Surgery
- Organ Transplantation
- Emergency Medicine and Intensive Care
Link:The Bambino Gesù Children’s Hospital, its history and its organization