conect4children operates a pan‑European clinical trial network that supports pharmaceutical and academic sponsors in designing and executing pediatric studies. It provides a Strategic Feasibility Advice Service, national hub coordination of sites, patient‑centred engagement tools, an academy for GCP and data‑standard training, and integrates real‑world data with CDISC‑aligned models to produce regulatory‑grade protocols and submissions.
Funding
Funding not disclosed
Founders
Product
Problem
Pediatric drug development often suffers from fragmented trial infrastructure, limited access to qualified sites, and insufficient patient and caregiver involvement, leading to delays and higher costs in bringing medicines to children. Regulatory requirements for age‑appropriate study designs further complicate trial planning across multiple European countries. Consequently, many potential pediatric therapies never reach the market.
Solution
conect4children operates a pan‑European clinical trial network that centralizes expertise, sites, and resources to streamline the design, feasibility assessment, and execution of pediatric studies. The network provides a Strategic Feasibility Advice Service (SFAS) that leverages a pool of over 450 clinical and methodological experts to generate regulatory‑grade protocols and pediatric investigation plans. National Hubs coordinate site identification, feasibility screening, contract negotiation, and patient recruitment across 21 countries, ensuring consistent quality and rapid activation. Integrated patient‑public involvement tools and educational toolkits empower children and families to contribute to trial design and consent processes. A dedicated Academy offers training modules, workshops, and certification to harmonize trial conduct and data standards. Real‑world data integration and CDISC‑aligned data models support interoperable data capture and regulatory submissions. Multi‑stakeholder meetings and specialty networks facilitate continuous dialogue among industry, academia, regulators, and patient groups, aligning research priorities with clinical needs.
Target Audience
Primary customers are pharmaceutical companies and biotech firms developing medicines for children, as well as academic investigators and clinical sites seeking regulatory‑grade trial support across Europe. The network also serves regulators, patient advocacy groups, and healthcare professionals involved in pediatric drug development.
Features
- Strategic Feasibility Advice Service (SFAS) with expert panels that produce regulatory‑grade protocols, natural‑history inputs, and endpoint recommendations.
- National Hub infrastructure providing standardized site feasibility assessments, contract templates, and recruitment dashboards for rapid trial start‑up.
- Patient‑centred engagement platform offering toolkits, consent aids, and Young Investigator Community resources to incorporate patient voices early.
- Academy learning environment delivering accredited courses on GCP, pediatric trial methodology, and data standards (CDISC, FAIR).
- Integrated real‑world data pipeline enabling linkage of electronic health records to trial datasets for enriched safety and efficacy analyses.
- Multi‑stakeholder meeting framework that convenes regulators, industry, clinicians, and patient advocacy groups to co‑define unmet needs and study priorities.
- Harmonized data collection templates and semantic interoperability guidelines to ensure cross‑site data quality and regulatory compliance.