"special care when working in trials involving paediatric patients"
Many drugs which have been used for the treatment of children have not been originally developed for them. Moreover, the use of unlicensed and off-label medicines is also common among children affected by rare diseases.
Regulatory agencies have implemented multiple initiatives to improve and support drug research in pediatric population. They have created incentives and obligations for biopharmaceutical companies to perform high quality research and gather more evidence of pediatric safety and efficacy with the intent to bring more effective and safer treatments for children.
At orphan reach, we are specialized in conducting studies in pediatric population and pediatric rare diseases. We are here to support you with necessary regulatory requirements for pediatric indications as well as executing your pediatric clinical trials with high quality data.
Our Paediatrics research experience includes:
• A proven track record of 147 studies ranging from phase I to phase IV, observational studies across 25+ countries
• 44 studies in pediatric orphan diseases
• Successfully recruited patients globally