We offer complete support for paediatric clinical trials
We know that designing and conducting trials, and then reporting progress to meet regulatory requirements – while still adhering to timelines – is a daunting task, and one that puts all concerned parties under pressure. Auxiliis can relieve you of these worries. We use our experience to manage all aspects of your proposed paediatric trials – designing the research, implementing the trials, and submitting the final research reports for review by regulatory authorities.
Paediatric Drug Development: help from beginning to end
A well-thought paediatric drug development strategy is no longer an option. Existing regulations in EU and US require drug developers to think about studies in younger patients early in the process. Eraly consultation with regulatory bodies (FDA and EMA) about paediatric development is certainly recommended. Auxiliis can support you in this process from the very beginning and help you define a successful paediatric development strategy
Auxiliis can advise you on study design, clinical assumptions, endpoints in clinical trials, site selection and further details. It narrows down during the execution phase to proper monitoring, adequate home visits to patients where required, and finally support with the management of the study results.
You always get what you need from Auxiliis.
To focus on our goal of improving children’s healthcare, we ensure special protection and guidance is given to the children participating in clinical research. We understand the ethics of care for this vulnerable population and have the experience with paediatric trial design and execution to ensure that participants both benefit from medical progress and avoid exposure to unnecessary risks.