Oksana Fabri, PhD, MD
Executive Medical Director,
Therapeutic Area Medical Lead,
Hematology/Oncology
Looking for a Pediatric CRO Partner?
Our pediatric CRO services are designed specifically for the nuances of pediatric clinical trials
We help biotech sponsors run regulatory-compliant, patient-centered pediatric clinical trials across rare, genetic, and complex conditions. Our full-service pediatric CRO model supports sponsors from preclinical through post-market approval.
Advancing Innovation in Pediatric Drug Development
Our commitment to innovation is at the core of our pediatric drug development strategy
We help biotech sponsors deliver transformative therapies to children with precision and care. From neonates to adolescents, our pediatric team ensures regulatory alignment and supports pediatric clinical research initiatives, operational efficiency, and family-centered trial design.
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Why Pediatric Clinical Trials Require Specialized Expertise
Allucent’s experience spans pediatric therapeutics from rare diseases to broader population studies
Pediatric clinical trials demand more than operational know-how. They require a deep understanding of ethical standards, evolving regulatory requirements, and the unique physiological, developmental, and emotional needs of young patients. Whether you’re developing a treatment for a rare genetic disease or extending an adult indication, our pediatric CRO team helps navigate the complexities with confidence. As a specialized pediatric CRO, we offer operational and regulatory support across all phases.
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Top Challenges in Pediatric Drug Development – and How We Help
Our pediatric CRO services are tailored to overcome these barriers effectively
Small Patient Populations
Rare pediatric diseases often involve very limited patient numbers, making recruitment and retention difficult. We tap into global pediatric networks and registries to identify eligible patients quickly. Our relationships with top children’s hospitals and KOLs ensure early engagement and trust.
Ethical and Regulatory Complexities
Pediatric trials face higher regulatory scrutiny and require age-appropriate ethical frameworks. Our team supports development and submission of pediatric study plans (iPSP/PIP) and creates consent and approval processes tailored for different age groups, ensuring compliance and caregiver engagement. Our pediatric clinical research capabilities include crafting ethical, age-specific protocols.
Age-Appropriate Dosing and Formulations
Children require formulations that are safe, tolerable, and easy to administer. We collaborate with formulation scientists and apply our pediatric pharmacology expertise to support dose selection, palatability, and delivery methods suited for young patients.
Caregiver Engagement and Retention
Parents and guardians are critical stakeholders in pediatric trials, and their experience impacts compliance. We provide communication strategies, educational materials, and family-centric trial logistics that reduce burden and foster sustained participation.
Pediatric Experience
110+
Pediatric Trials
2000+
Global Sites
17000+
Pediatric Patients Recruited
Comprehensive Pediatric Expertise Across Therapeutic Areas
Genetic Disorders
- Spinal muscular atrophy (SMA)
- Duchenne muscular dystrophy (DMD)
- Lysosomal storage disorders (e.g., Gaucher, Pompe)
Rare Disorders
- Pediatric epilepsy syndromes
- Inborn errors of metabolism
- Pediatric neurology research initiatives – CNS and neurodevelopmental disorders
- Autism spectrum disorders
- ADHD
- Pediatric migraine
Oncology (numerous pediatric oncology trials across global sites)
- Pediatric acute lymphoblastic leukemia (ALL)
- Neuroblastoma
- Medulloblastoma
- Pediatric solid tumors
Infectious Diseases and Vaccines
- RSV, influenza, COVID-19
- Pediatric vaccine development
Endocrine and Metabolic Disorders
- Type 1 diabetes
- Pediatric growth hormone deficiency
Pediatric CNS Disorders
- Neuroinflammatory conditions
- Pediatric movement disorders
Pediatric-Focused CRO Services
- Pediatric formulation and dosing support
- Child-friendly assent/consent materials
- Caregiver and advocacy engagement
- Pediatric PK/PD and safety monitoring
- Global network of children’s hospitals and specialty sites
Global Regulatory Strategy
- Pediatric Study Plans (iPSP/PIP) development and agency engagement
- Pediatric waiver/deferral planning
- Experience with orphan pediatric indications
- Adaptive designs and Bayesian models in small populations
Operational Strengths
- Pediatric clinical trials experts
- Seasoned pediatric investigators and research staff
- Recruitment strategies tailored to families and caregivers
- Access to rare pediatric populations via global registries enables us to quickly mobilize for pediatric clinical trials across challenging indications
- Remote monitoring and telehealth integration
As Senior Medical Director of Pediatrics, I’ve seen firsthand the exceptional quality and commitment Allucent brings to every pediatric trial. We deliver not just operational excellence, but trusted strategic partnership especially for small to mid-size biotech sponsors navigating complex development paths. Our teams combine scientific rigor, regulatory insight, and compassion to accelerate safe, effective treatments for children worldwide. I’m proud to be part of an organization where quality, care, and client trust drive every decision we make.
Ilze Balode, MD
Senior Medical Director, Pediatrics
Meet Our Pediatrics Experts
Our Pediatrics A-Team brings backgrounds in neonatology, rare disease, cell and gene therapy and regulatory strategy. We work closely with key opinion leaders and global pediatric working groups to advance trial design and access for underserved populations.
- Over 16 years of experience in the fields of hematology, oncology, and stem cell transplantation
- Extensive knowledge of current treatment approaches, emerging therapies, and regulatory developments
- Offers expert guidance in medical oversight and strategic planning for clinical trials in related areas
Ilze Balode, MD
Sr. Medical Director,
Rare Diseases
- Pediatrician and neonatologist with 20+ years of experience in clinical research and all aspects of clinical trials, including gene therapies
- Experience in many rare pediatric indications and treatment modalities
Let's Talk
Connect with our pediatric clinical development team to discuss how we can support your next pediatric study.
Related Content
Additional Resources
Webinars
Transforming Pediatric Rare Disease Trials Through Modeling and Simulation and Site Networks
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Infographics
De-Risking Rare Pediatric Trials with Modeling and Operational Integration
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Webinars
Pediatric Clinical Trials: Tackling Clinical and Therapeutic Development Challenges Head-On
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FAQs
A pediatric clinical trial is a research study designed to test the safety and efficacy of a drug, biologic, or medical device in patients under 18, from neonates through adolescents. These trials assess differences in how children and adults respond to a treatment, including appropriate dosing, formulation, and delivery methods specific to each age group.
Pediatric trials require age-specific consent and assent processes, added ethical oversight, and dosing that accounts for a child's physiological and developmental stage. They also demand age-appropriate formulations, such as liquids or chewables, and family-centered trial logistics to support caregiver participation and reduce burden on families.
Sponsors should look for a CRO with proven regulatory experience with iPSP and PIP submissions, pediatric pharmacology expertise for dose selection and formulation, established pediatric site networks, and caregiver engagement strategies to support enrollment and retention.
Allucent has run 110+ pediatric trials across 2,000+ global sites, recruiting more than 17,000 pediatric patients. The team supports sponsors from preclinical through post-market approval, with specialized experience in genetic disorders, rare diseases, and pediatric oncology.
For recruitment, Allucent taps into global pediatric networks and registries alongside relationships with top children's hospitals and key opinion leaders, to identify eligible patients despite small population sizes. For retention, the team provides caregiver communication strategies, educational materials, and family-centric trial logistics designed to reduce burden and sustain participation.
Yes. Allucent has a wealth of experience across genetic disorders including spinal muscular atrophy (SMA), Duchenne muscular dystrophy (DMD), and lysosomal storage disorders such as Gaucher and Pompe disease, as well as rare disorders including pediatric epilepsy syndromes, inborn errors of metabolism, autism spectrum disorders, ADHD, and pediatric migraine.
Yes. Allucent has experience across pediatric oncology indications including acute lymphoblastic leukemia (ALL), neuroblastoma, medulloblastoma, and pediatric solid tumors, backed by a global network of 2,000+ trial sites.
Pediatric rare disease clinical trials typically involve small, geographically distributed patient groups, limited early clinical data, strict sampling, and complex recruitment. Allucent helps sponsors address these challenges through model-informed techniques, such as population PK modeling, allometric scaling, adult-to-pediatric extrapolation, and clinical trial simulation, to help optimize dose selection as well as decrease patient burden. Our experienced pediatric site networks also help enable trial feasibility by expediting site start-up, accessing unique patient groups, and enhancing recruitment and retention.