Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari – Ospedale Pediatrico “Giovanni XXIII” is a university hospital encompassing paediatric and non paediatric expertise in different therapeutic areas in the Apulia Region. It is a reference centre for: paediatric oncology, haematology, rare diseases, neonatology, emergency, cardiology, endocrinology, neuropsychiatric, gastroenterology. Beside a long-standing clinical expertise, it has laboratory and diagnostic facilities, including instrumental, imaging MRI, TAC, data-banking, immunology, biomarkers, allowing experimental procedures are conducted as required by study protocols and Good Clinical Practices (GCPs).
It is currently involved in several multicentre and multinational paediatric research activities and in 2018 will lead the PROMISE project “Multi-centre, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon-beta 1a (IFN-beta 1a) weekly i.m. and glatiramer-acetate (GA) in paediatric patients affected by multiple sclerosis”. In 2016, an agreement between CVBF and Policlinico of Bari – Ospedale Pediatrico “Giovanni XXIII” has established an integrated Platform for Paediatric Clinical Research (PI-CPR), aimed at the creation of a Paediatric clinical trial center, with the final aim to simplify and facilitate the management of paediatric clinical research.
This platform will include the following activities: planning, design studies with innovative models, documentation preparation and submission for ethics committees and regulatory authorities, pharmacovigilance, experimental drug administration.
In the framework of this project, it will:
- contribute in the setup of a local units supporting research infrastructure at local level in collaboration with CVBF, FGB and UNIBA (WP4);
- propose case studies for the WP 9 (Thematic platform to relate work that underpins medicines development to paediatric clinical studies).
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