We have performed, over our history:
- 310+Clinical Studies
- 25+Indications
Biotech and pharma companies today face increased regulatory requirements for pediatric trials as they address the need to advance treatments for diseases unique to children. Pediatric development plans are a requirement for new drugs in the US and EU, and pediatric clinical research is on the rise. Recruitment, ethical, scientific, logistical challenges, and product labeling all pose specific needs in studies aimed at children.
At Synteract, we understand pediatric development. Our recent acquisition of KinderPharm builds on Synteract’s extensive experience in navigating complex regulatory environments and commitment to pediatric drug development. With advanced pharmacometric modeling and clinical trial simulation technologies, juvenile formulation, and toxicology services across pediatric indications we offer both preclinical and clinical drug development services.
Our single source model services:
- Pediatric Waiver & Deferral Submissions
- PIP and PSP Submission
- Age appropriate formulations
- Juvenile toxicology studies
- Dose extrapolation
- PK/PD modeling and simulation
- Population PK/sparse sampling strategies
- Phase I – IV clinical studies
- Regulatory submissions
Why work with Synteract for pediatric clinical trials?
There are many reasons to work with Synteract. But there are 5 key reasons to work with Synteract for pediatric trials that are of particular importance.
In addition, we are at the forefront of working with sponsors in this space, having conducted 310+ pediatric clinical studies, globally. Our pediatric cross-functional team helps clients navigate the complexities of pediatric research and provides tailored pediatric development planning and experienced technical and operational services to allow medicines to reach patients in need, including medical and regulatory strategy, protocol development, trial design as well as submission, follow-up and updates of PSPs and PIPs.
“Pursuing our full commitment to pediatric development, we are now integrating Synteract’s existing base of experience and leadership with the focused knowledge and expertise that KinderPharm has provided its clients for many years. Together we become the leading CRO for pediatric services, delivering a single source model for preclinical and clinical development, along with the specialized operational and logistical understanding required in working with children and their families.”
Steve Powell, CEO Synteract
We understand the level of compassionate and specialized clinical and regulatory expertise required in working with vulnerable pediatric populations and their families. We collaborate with international pediatric networks, opinion leaders, patient advocacy groups, and regulatory bodies key to pediatric development and pediatric success, and capitalize on relationships with global partners invested in this patient population. Many of our executives are actively involved in the industry.
Contact us today to learn how our clinical experts can guide you through evolving global regulations and data requirements each step of the way.
