Addressing the Growing Need for Medications for Children
Pediatric development plans are a requirement for all new medicines, indications, dosing forms, regimens, and routes of administration, and pediatric clinical research is on the rise. Additionally, all applications for marketing authorization for new medicines must include the results of studies in children as described in an agreed-upon pediatric plan, unless the medicine is exempt because of a deferral or waiver.
Understanding the Diversity of Pediatric Clinical Trials
At Synteract, we are at the forefront of working with sponsors in pediatric drug development with broad experience in 310+ studies across 6 continents, in 62+ countries.
Conducting Pediatric Clinical Trials with Heart
Pediatric drug development requires special care in recruitment to address ethical, scientific, and logistical challenges. We understand the compassionate, specialized clinical and regulatory expertise required when working with vulnerable pediatric populations and their families. We have experience working with international pediatric networks, opinion leaders, patient advocacy groups, and regulatory bodies, with many of our executives actively involved in the industry, and can capitalize on relationships with global partners invested in this patient population.