INCiPiT is the Italian Network for Paediatric Clinical Trials, which acts as a c4c National Hub (NH) in Italy.

As good Italians who respect history, we can say the incipit of INCiPiT was in 2017. From the very beginning, INCiPiT was conceived as an independent legal entity, which officially came to life in November 2017 and it has been structured as an emerging network within c4c, with a firm commitment to create a sustainable, efficient and dedicated national network for paediatric clinical studies in Italy.

INCiPiT is a non-profit Consortium currently composed of 15 partners, including leading Italian Paediatric Hospitals and Research Organizations and International Networks coordinated by Italian entities. The Partners together constitute the General Assembly of the Consortium, whilst the Board of Directors, composed of five Members including the President, has all the powers for the ordinary and extraordinary management of the Consortium. Within our Network we organize, on a monthly basis, periodic online meetings and f2f ones, either to discuss strategic and operational topics, or to share ideas and best practices, to discuss challenges and opportunities of the Consortium, with the main purpose to engage the INCiPiT Partners.

We intend to promote the growth and improve the quality of paediatric clinical studies in Italy. We provide concrete support for the planning, implementation and completion of all types of paediatric clinical studies and trials (profit and non-profit). The Consortium makes interconnection among its partners its greatest strength.

The independent status of INCiPiT is a very important feature because, while this implies a demanding administrative/legal/financial management, it also allows the Consortium to be untied from the individual Partners that are part of it and provides important formal and operational independence. This has made it possible, for example, to be a beneficiary of the c4c project, to participate as a legal entity in European projects and to act as Sponsor in clinical studies.

Since it was established, the Consortium has gained a lot of experience and visibility in the Italian landscape and we can say that as of today INCiPiT represents a unique contact point for the Sponsors/CROs/Academia/Scientific Societies/Research Infrastructures in our Country. The main tasks in which INCiPiT is engaged to date are: feasibility and site identification, support in the c4c proof of viability (PoV) studies, management as Sponsor of two multicenter paediatric clinical studies conducted in Italy, regulatory consultancy for the development of drugs to be used in the paediatric population, support to INCiPiT clinical sites for the ethical/regulatory submission and management of academic-driven clinical trials. We are involved across the board in tackling challenges and supporting the world of pediatric studies, trying to turn difficulties into opportunities for better quality of children’s life.

We take here the opportunity to announce that the Italian NH team is now led by Francesca Rocchi, Pharmacologist, responsible for the Regulatory Affairs Service of the “Clinical Trials Area for the implementation of drugs, vaccines and devices for pediatric use” at Bambino Gesù Children’s Hospital. Francesca and the other four INCiPiT Board of Directors Members have been very recently elected, at the end of January 2024. The rest of the Team is the very operational heart of the NH, working on a day-by-day basis in the various activities, consists of three Clinical Project Managers: Lucia Di Maggio, Sara Abbate and Anna Benedetta Del Signore and an Administrative Manager: Silvia Fioravanti and communication manager: Giulia Neccia (unfortunately not in the photo of the team!).

 

We, as the INCiPiT NH Team, believe that there are many opportunities for improvement and new projects for the INCiPiT Consortium to come: we will work hard to keep the level of initiatives high! Good luck to us 😉

Visit the INCiPiT website to find out more!