Pediatrics
Children deserve more than scaled-down science. We deliver personalized, patient-centric solutions that enable us to navigate the unique complexities of pediatric trials – together.
Patient and family-centric pediatric trials
Pediatric studies demand an elevated level of attention. From defining age-appropriate inclusion and exclusion criteria to identify eligible participants and selecting experienced pediatric sites, we ensure that the design and delivery of your trials are attuned to the specific physiological, developmental, and emotional needs of young patients.
Pediatric experience that matters
We operate as an extension of your team, bringing flexibility, transparency, and a sense of ownership. Our specialized expertise in pediatrics, clinical operations, regulatory compliance, and study delivery yields the high-quality data you need for informed decision-making.
We proactively manage the complexities of pediatric trials with strategies that reflect the needs of the child—and their family.
- Tailored Trial Designs: Balancing efficacy and safety while minimizing burden: we design every visit, assessment, and procedure with pediatric needs in mind.
- Age-Appropriate Formulations: Expertise in child-friendly dosage forms: orodispersible tablets, liquids, chewables—developed to meet taste, texture, and dosing requirements.
- Smart Sampling Protocols: Adhering to minimal-risk standards for blood draws and using small-volume techniques and indwelling catheters to reduce trauma.
High-touch pediatric trials
We design and execute your pediatric trials with the end in mind. With the medical and operational expertise and ability to adapt on the fly, we focus on easing the burden of patients and their families.
Advance your pediatric study with skilled leaders
With a keen awareness of pediatric patient population, we work in partnership with you to ensure the safety regulatory compliance and ease-to-participate of your trial. Jonathan Kornstein, Vice President, Rare Disease and Pediatrics leads our team of operational, clinical, and medical specialists. Jonathan has 30 years of industry experience and oversees clinical trial services, applying his experience supporting rare disease and pediatric clinical trials. Jonathan also delivers strategic consultation and direction to our clinical management and commercial development teams, helping facilitate success in clinical trials.
Jen Truong, MD, MPH is our Senior Medical Director for Pediatrics. She is a pediatrician and experienced clinical research leader with over 15 years in pediatric drug development. She has led global pediatric clinical trials across all phases, with a focus on regulatory strategy, patient safety, and ethical study design. Her expertise bridges frontline pediatric care and complex clinical research, and she brings those insights to our clients as a trusted partner in advancing therapies for children worldwide.
Advancing life-changing therapies
“Our mission is to move pediatric research forward while easing the burden on children and their families. By collaborating closely with sponsors, we help navigate the complexities of pediatric trials and accelerate access to much-needed therapies for young patients facing serious health challenges.”
Jonathan Kornstein, Vice President, Rare Disease and Pediatrics
Passionate about better trials
“We’re passionate about understanding what pediatric patients and their families go through so we can design and deliver better trials – to get better medicines for patients in need.”
Jen Truong, Senior Medical Director Medical Affairs
Global expertise with local insight
Pediatric studies require specialized consideration: formulations, consent/assent strategies, scheduling, and more. We understand how to operationalize these needs across diverse regulatory landscapes.
- Comprehensive Regulatory Knowledge: From the U.S. PREA and PSP requirements to EMA’s PIP frameworks, we navigate global regulations to ensure compliance and timely approvals.
- Multinational Site Experience: We partner with academic and specialist pediatric networks (e.g., Enpr-EMA, PTN, NIHR CRN) and use advanced feasibility tools to select optimal sites.
Speak to a global expert
Access the right people when and where you need them with personalized clinical services tailored to you and your trial.
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