Setting-up a high quality, compliant and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for companies. To ensure the safety of all participants in academic studies and that the PV system fulfils all regulations, we set up a centralized PV system that allows sponsors to delegate work…
Clinical, methodology, and patient/carer expert advice in pediatric drug development by conect4children – CTS Journal – Wiley Online Library Many medicines are used “off-label” in children outside the terms of the license and feasible pediatric clinical trials are a challenge to design. Conect4children (c4c) is an Innovative Medicines Initiative project to set up a…
conect4children is pleased to announce that the third c4c International Multi-Stakeholder Meeting (MSM) will address medical devices in paediatric type I diabetes.
