The Right Expertise
PPD is a leading clinical researcher in pediatric drug development, having conducted more than 200 pediatric clinical trials in some 95 countries, enrolling more than 93,000 patients at 4,600 sites, across a range of therapeutic indications, including infectious diseases, cardiology, oncology and immunology.
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 pediatrics. As development in pediatric 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.
It is vital to have the appropriate expertise to identify issues and plan mitigation strategies and to manage the execution of clinical studies and associated development activities in this unique setting.
End-to-End Services Across Pediatric Drug Development
Our broad range of services means we are able to assist clients in conducting pediatric 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 pediatric 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 pediatric expertise
- Participation in pediatric regulatory activities to assist with development and execution of global regulatory strategies and dossier preparation
- Broad awareness of the global pediatric development landscape
Significant Experience in Pediatric Drug Development
In addition to client consultation, PPD’s pediatric practice area provides support and consultation to internal study teams during study conduct to maintain continuity of operational execution.
PPD also has a deep understanding of and familiarity with the ethical issues attendant upon clinical trials in children, enabling us to identify sites with the appropriate regulatory structures and processes and investigators with relevant expertise who support the conduct and execution of studies to the highest ethical standards.