Activities and Services
Activities
Thanks to the detailed knowledge of the Italian Clinical Sites and the on-the-spot presence of INCiPiT representatives within them, the Consortium helps the centers participating in the clinical studies cooperate, by facilitating the exchange of information, results, data and expertise.
The Consortium can play different roles in the clinical studies in which it is involved, from regulatory promoter to feasibility coordinator or provider of other services especially for the non-profit studies.
As part of the European Conect4Children (c4c) project, one of the leading European initiatives dedicated to pediatric clinical research - INCiPiT served as the Italian National Hub and fostered the development of the European network by promoting the exchange of knowledge among experts in the field and offering opportunities for specialized training through courses dedicated to pediatric clinical research offered by the c4c Academy. Following the project’s conclusion on April 30, 2025, INCiPiT continues to serve as the Italian National Hub within the c4c-Stitching (c4c-S) initiative, ensuring the continuity of networking, training, and support activities for pediatric clinical research.
Services
Thanks to the expertise of the Members of the Consortium and its Coordination Center Team, INCiPiT carries out various services in the field of Pediatric Clinical Research, from feasibility activities to Scientific Consulting for Profit and Non-Profit Studies:
Scientific Advice
- On the Pediatric Investigation Plans (PIPs)
- On the Protocol Development
Feasibility and Site Identification
- System to reach all Centers
- Selection of the most suitable Members
Regulatory and Ethics
- Support to the preparation and submission packages to ECs and NCA
- Interaction with ECs and NCA during the process
Optimize Study Delivery
- Support of the Study Start Up
- Synergy within the Partners and improved efficiency of: recruitment and FU strategies, communication within the Centers and YPAG involvement
Learning and Education - c4c Academy
- Dedicated Virtual Learning Environment Platform
- GCP Training for all investigators
- Other dedicated basic and advanced courses/training programs