WP3: Tools for neonatal & paediatric clinical trials

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)