The French National Node, represented by Milo Health, a digital health and clinical research technology company specialising in clinical trial software and electronic data management solutions, provides a dedicated contribution in digital clinical research infrastructures, supporting the design, conduct, and management of paediatric clinical studies through secure, regulatory-compliant electronic platforms, and strengthening the capacity for efficient, high-quality, and secure paediatric clinical data collection and management across European translational research networks.
The core activity is the provision of advanced Electronic Data Capture (EDC) services integrating electronic Case Report Forms (eCRF) and electronic Patient-Reported Outcomes (ePRO). These services enable secure, structured, and real-time collection of clinical trial data, supporting study setup, data acquisition, monitoring, validation, and preparation of datasets for interim and final analyses. Particular emphasis is placed on paediatric research through age-appropriate digital interfaces, caregiver-assisted reporting functionalities, multilingual environments, and tools designed to improve patient engagement and data quality in children and adolescents. The French Node operates through the MILO platform, a cloud-based clinical research environment compliant with ISO 14155, 21 CFR Part 11, GDPR, and EU regulatory requirements. The platform provides configurable eCRF and ePRO modules, real-time data validation, audit trails, query management systems, recruitment monitoring dashboards, and export-ready datasets compatible with international clinical data standards. Integration capabilities extend to electronic consent systems, electronic health records, clinical trial management systems, wearable devices, and remote monitoring technologies, supporting decentralised and multi-centre clinical studies. In addition to data capture services, Milo Health contributes expertise in digital trial design, regulatory-compliant data management, clinical study digitalisation, and implementation of interoperable research infrastructures.