For investigators :
- Facilitator of research in all disciplines of pediatrics, including rare diseases, the PEDSTART network can be involved in all phases of a research project starting at the conception of the protocol:
- Scientific expertise
- Methodology consultation
- Study feasibility within the network
- Administrative and technical or regulatory support (budget, regulatory procedures)
- Optimise site set-up
- Optimise recruitment and monitoring of inclusions
- Help in formatting European projects
PEDSTART can :
- Inform pediatric clinical studies for which PEDSTART has been solicited
- Aid in the evolution of legislation in terms of clinical research
- Facilitate the assembly of scientific projects by giving access to the means and research centers of the PEDSTART network
- Support investigators in writing study documents and obtaining specific authorizations
- Accompany project leaders in a quality approach
For sponsors :
The PEDSTART network also offers services for the pharmaceutical industry and academic sponsors in France and internationally
- Establishment of clinical trials under optimized and harmonized conditions
- « Proof of concept » studies – early phase trials
- Evaluation of new medicines
- New uses for existing medicines
- Strategic therapeutic trials
- Implementation of pharmaco-epidemiological studiess
- Promote the establishment of bio-banks and registries
- Facilitate the recruitment of patients in clinical trials and pharmaco-epidemiological studies
Quality Assurance
Anglais