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Clinical Trial Center
In light of the assessments by the Paediatric Committee at the European Medicines Agency (EMA), there will be a significant increase in studies of medicines for children aged 0 to 17 in compliance with the new Paediatric Regulation. The quality assurance of dosage, formulations, safety, and efficacy of the therapy in child development age will be more accurate. The Ospedale Pediatrico Bambino Gesù established the Clinical Trial Center in January 2010 in order to meet the needs for conducting clinical trials for the paediatric use of medicines. It has organised investigation plans and studies promoted by industries, scientific agencies, research institutes and individual investigators that were conducted locally as well as coordinated nationally and internationally.
VISION & MISSION
To be a point of reference for clinical trials and studies of paediatric medicines and provide clinical and scientific leadership as well as support infrastructures to assist young patients.
Foster excellence and quality in paediatric clinical trials in compliance with Good Clinical Practice guidelines and provide paediatricians with the necessary tools to conduct high quality research.
The Clinical Trial Center is committed to:
- ensuring that Good Clinical Practice is applied to clinical trials on paediatric patients;
- promoting and safeguarding ethical standards in paediatric research;
- establishing a positive and motivated working environment that fosters team work, mutual respect, integrity, receptiveness and interest in the project, and creative interdisciplinary scientific interaction.