From start to finish, we manage pediatric clinical trials to deliver the right data required by regulatory agencies across the globe. It’s not easy, it’s a very special population, and regulatory approvals remain challenging due to the ethical and logistical issues surrounding these studies. But we understand it better than most: the nuances of assent and informed consent, the trial design, even the planning and execution, which we approach from the perspective of the child and the family. With INC Research, your pediatric clinical trials are in safe hands.
We have a specialist Pediatric Team who really knows its stuff. With over 20 years experience working on global pediatric trials, 470+ Phase I – IV studies and consulting projects across all therapeutic indications, over 125,300 pediatric patients (preterm, newborns, infants, children and adolescents) spanning six continents, our wealth of therapeutic and regulatory experience means we can give you the confidence of knowing you’ve made the right choice.
Pediatric Experts Network
In order to address the many and varied challenges of pediatric clinical trials, we have formed the Pediatric Experts Network (PEN). The PEN is a forum for pediatric experts to define our approach to pediatric clinical studies. Its mission is to provide direction and governance on pediatric development across all of our therapeutic business units. The forum facilitates engagement of representatives from different functional groups who are experienced in, and focused on, pediatric clinical trials.
What can PEN bring you?
- Regulatory guidance and services for FDA (Pediatric Exclusivity and PREA) and EMA (Pediatric Investigation Plan (PIP)
- Program/Plan development and writing
- Study summary and full protocol design and writing
- Informed Consent and Assent for development including country specific standards
- Global feasibility and pediatric site identification
- Organization and management of data monitoring and safety committees
- Pediatric medical consultancy
- Medical monitoring by pediatricians
- Patient enrollment and retention documents and strategies
- Pediatric training for pharma and biotech companies
- Study execution of clinical trials across all pediatric age groups
Our work in practice
For a double blind study in children with complicated intra-abdominal infections, we needed to identify qualified sites around the globe and successfully achieve enrollment of patients meeting strict entry criteria in an acute care setting.
We provided consistent, effective central management and implemented site specific recruitment strategies to prescreen over 6,000 patients.
Following comprehensive site identification and selection activities, and strategic regulatory and ethics submissions management, we successfully initiated 73 sites across 18 countries in Europe, North and South America, and successfully enrolled 450 children across 4 pediatric age cohorts, including 220 patients participating in PK assessments.
Our multidisciplinary approach leveraging our pediatric physician disease area specialists, pediatric trial operational experts, regulatory consultants, and long standing history of delivering quality and timely data for many pediatric programs gives you the confidence that you are choosing the right CRO for your needs.
We are a market-leading CRO with decades of experience to help you improve medical treatment for children.