To date, 16 European countries have signed the cooperation agreement with c4c-S, marking an important step towards an increasingly broad and integrated network. Italy actively participates in this network through INCiPiT, which serves as the Italian National Hub.

The c4c-S network is at the core of its mission to promote efficient, collaborative, and high-quality pediatric drug development. It is built on two fundamental pillars:

• Expert Groups: multidisciplinary teams of clinical and methodological experts, together with patient representatives, providing scientific and strategic advice.
• National Hubs: national reference points that coordinate operational activities within their respective countries.

INCiPiT plays a central role within c4c-S by providing strategic services to facilitate pediatric clinical research in Italy, including:

• Site Identification and Feasibility: coordination of clinical site selection and study feasibility assessments through an extensive network and in-depth knowledge of Italian research centers.
• Clinical Trial Support: assistance with study start-up and management, including contract negotiation and coordination with participating sites, helping to accelerate study activation.
• Expert Consultancy: participation in Expert Groups, providing advice on study design, protocols, Pediatric Investigation Plans (PIPs), Pediatric Development Plans (PDPs), and regulatory strategies.