In order to inprove medicines for children, these medicines need to be tested in the paediatric population by conducting clinical trials involving children and young people (0-17 years). Before starting a clinical trial, the study protocol and research plan must be approved by ethical committees and regulatory authorities to ensure quality of the study and to protect potential study participants. Addionally, local approval is needed before a study can start. These processes are regulated by legislation and regulation and Pedmed-NL can support you with these processes, we work following related standard operating procedures.
Children deserve the chance to participate in these trials and these trials should be of the highest quality possible.