PAEDIATRIC INVESTIGATIONAL PLANS
In the last decades, the need to facilitate children access to new medicinal products has considerably influenced drug development. Physicians and drug agencies have stressed the need for children to have access to new treatments adapted to their age, weight, and physiological development.
Drug development in the paediatric population is therefore an important challenge to the pharmaceutical industry due to additional constraints to the overall plans, mainly in the nonclinical and clinical programmes, drug formulation and overall planning.
- Paediatric Needs
We assist you identify paediatric needs that could be fulfilled with your medicinal product, through the analysis of available marketed drugs and their positioning.
- Paediatric Investigational Plans
We help you write and produce appropriate paediatric investigational plans (PIP) through the analysis of the disease epidemiology and paediatric needs.
- Health Authorities Expectations
We advise you on age-adapted drug formulation and dosages consistent with Regulatory Authorities and physician’s expectations.
- Clinical Protocols
We help you develop and write paediatric clinical protocols to be submitted as part of a PIP or a paediatric-use marketing authorisation (PUMA) or following an FDA Written Request.
- Academic Support
We help you identify key experts in the field of interest and constitute advisory boards, data and safety monitoring boards (DSMB) for the supervision of your paediatric clinical trials.