Paediatrics

GCR is a leading clinical researcher in paediatric drug development.

We understand the challenges associated with conducting clinical research in children.

The impact of these complexities can have a significant impact on the time, cost and quality of development programs in paediatrics. As development in paediatric indications continues to expand, the industry is experiencing an increase in the number, size and complexity of industry-sponsored clinical trials in children and adolescents.

Paediatrics

Paediatric Drug Development

Our broad range of services means we are able to assist clients in conducting paediatric studies at any stage of development. Specifically, our expertise includes:

  • Insight into protocol development, feasibility, study design and study-related issues based on knowledge of current standard of care and regulatory trends, representing each geographic area of clinical development
  • Strategic consultation internally and externally on paediatric product development, through multidisciplinary clinical teams with firsthand knowledge of challenges and risk mitigation strategies regarding consent/ascent, recruitment and retention that can streamline operations in global clinical trials
  • Consultation with sites on the appropriate regulatory structures and processes and access to investigators with relevant paediatric expertise
  • Participation in paediatric regulatory activities to assist with development and execution of global regulatory strategies and dossier preparation
  • Broad awareness of the global paediatric development landscape