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Objectives
- To develop or adapt tools to be used for multinational paediatric clinical trials; this entails upgrading tools already developed by participants, especially ECRIN, taking into consideration paediatric specifications
- To disseminate tools to PedCRIN and ECRIN partners
- To train and support partners on the use of the tools
Key activities
- Survey targeting paediatric and neonatal users as well as patient communities to identify the needs of paediatricians in terms of infrastructures and tools for clinical trials.
- Gap analysis to detect missing tools and services to support paediatric and neonatal trials
- Upgrade, maintenance and sustainability of tools for paediatric trials (ethical and regulatory database, pharmacovigilance, etc.)
- Upgrade, maintenance and sustainability of tools for neonatal trials
- Dissemination of the tools to PedCRIN and ECRIN partners
- Development of a procedure to enable access to individual patient clinical trial data
Partners
- Consorzio Per Valutazioni Biologiche E Farmacologiche (CVFB)
- Institut National de la Sante et de la Recherche Médicale (INSERM)