PedCRIN developed a series of tools (WP3) and procedures to support the setup and the management of multinational neonatal and paediatric clinical trials in Europe. These tools are developed to train and support researchers and clinicians so they can establish, run, and manage both paediatric and neonatal multinational clinical trials in a more effective and easier way. The removal of barriers to trial management will speed up the evaluation of new and improved therapies.Visit website
4c aims to generate a sustainable infrastructure that optimizes the delivery of clinical trials in children through:
a) a single point of contact for all sponsors, sites and investigators;
b) efficient implementation of trials, adopting consistent approaches, aligned quality standards and coordination of sites at national and international level;
c) collaboration with specialist and national networks;
d) high quality input into study design and preparation, through rigorous strategic and operational feasibility assessment;
e) the promotion of innovative trial design and quantitative scientific methods;
f) an education and training platform to shape the future leaders of paediatric drug development;
g) the development of sustainable support for all these activities.
Clinical Trial support
EORTC has developed a number of tailored tools and skills, enabling effective and qualitative management of increasingly diverse and complex clinical study data.
Clinical Trials tools, imaging tools, Molecular analysis tools, quality of life questionaires
Our databases include information from multiple sources, including clinical, radiotherapy, diagnostic, molecular imaging and biological samples.
Clinical development and regulatory affairs: highly specialized expertise and experience for the conception, preparation and realization of clinical trials, in collaboration with hospital-based investigators, and conform to both French and international regulatory frameworks.Visit website
• trial management operations (interaction with competent authorities & ethics committees, project management, monitoring, vigilance, data management)
• clinical trial tools (outcome measures, regulatory database, site locations, risk-based monitoring)