Oksana Fabri, PhD, MD
Sr. 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.
Learn More
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.
Learn More
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+
Trials
2000+
Sites
17000+
Patients
Comprehensive Pediatric Expertise Across Therapeutic Areas
Genetic Disorders
Genetic Disorders
- Spinal muscular atrophy (SMA)
- Duchenne muscular dystrophy (DMD)
- Lysosomal storage disorders (e.g., Gaucher, Pompe)
Rare Disorders
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)
Oncology (numerous pediatric oncology trials across global sites)
- Pediatric acute lymphoblastic leukemia (ALL)
- Neuroblastoma
- Medulloblastoma
- Pediatric solid tumors
Infectious Diseases and Vaccines
Infectious Diseases and Vaccines
- RSV, influenza, COVID-19
- Pediatric vaccine development
Endocrine and Metabolic Disorders
Endocrine and Metabolic Disorders
- Type 1 diabetes
- Pediatric growth hormone deficiency
Pediatric CNS Disorders
Pediatric CNS Disorders
We’re deeply involved in pediatric neurology research for conditions affecting brain development and function.
- Neuroinflammatory conditions
- Pediatric movement disorders
Pediatric-Focused CRO Services
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
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
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
Senior 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
Blog
ICH E11A: Key Features and Implications of the Pediatric Extrapolation Guideline
Learn More
Blog
Addressing the Unique Challenges of Cell Therapies for Pediatric & Geriatric Patients
Learn More
Webinar
Pediatric Clinical Trials: Tackling Clinical and Therapeutic Development Challenges Head-On
Learn More