Introduction: The conect4children (c4c) consortium was setup to facilitate the development of new drugs and therapies for paediatric populations and address key challenges associated with paediatric clinical trials. Two of the major adopting principles for c4c were academia-industry partnership and data harmonisation and interoperability through common eCRF definitions. To understand the challenges arising out of these principles, the c4c team at Newcastle University conducted semi-structured interviews with four c4c industry partners.Methods: Each partner was asked 10 questions about the data standards used in their company, management and maintenance of data dictionaries, how they dealt with paediatric-specific issues, major knowledge gaps and how academia could aid in bridging these gaps. Thematic analysis was performed to identify patterns in their answers.
Results: All companies use the Clinical Data InterchangeStandards Consortium (CDISC) standards but face problems when certain terminology is not included in CDISC
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