We’re powering innovation in pediatric clinical trial design and implementation—because half isn’t whole.
Clinical development in a pediatric population demands that the CRO has both a thorough medical understanding of the disease, as well as experience working with this vulnerable and special patient population. Pediatric trials involve unique challenges including recruiting, inclusion/exclusion criteria, subject compliance and retention. The enrollment of pediatric subjects in clinical trials has the additional complexity of family dynamics, legal status, and requirements of informed consent and assent. BBMCT understands that successfully implementing regulations and ethical standards into study conduct requires a comprehensive understanding of the unique concerns raised by ethics committees, investigators and parents.
Our experience crosses all therapeutic areas, including but not limited to:
- Oncology (ALL, AML, thrombocythemia)
- Hematology (anemia, hemophilia A and B, thalassaemia, thromboembolism, von Willebrand disease)
- Neurology (autism, epilepsy, multiple sclerosis, muscle atrophy, muscular dystrophy, Tourette’s)
- Infectious Diseases (influenza, rotavirus, clostridium difficile)
- Respiratory (asthma, allergy, cystic fibrosis)
- Psychiatry (ADHD, schizophrenia)
70% of the medicines given to children have only been studied in adults, and the majority of drugs used in children today are used off-label, without an adequate understanding of appropriate dose, safety, or efficacy. Our industry is still guessing the clinical needs of children by settling for a fraction of what works in adults. We’re changing that.
Deep and Broad Pediatric Experience
- BBMCT has built an experience base in the management of pediatric trials throughout our 05+ year history
- Management of studies in a wide range of therapeutic areas, including infectious diseases, type 2 diabetes, familial hypercholesterolemia, and neuroblastoma
- Experienced in rare disease and orphan indications which often involve pediatric populations
- Track record for developing and recruiting pediatric populations while maintaining ethical considerations both at a local and global level
We help our clients save time and resources by determining the feasibility and effectiveness of pediatric studies at every phase of a program. Our global experience allows us to develop and execute country-specific, customized recruitment and retention initiatives to help study teams meet or exceed goals. Issues critical to successful clinical development in pediatrics that we can assist with include:
- Regulatory strategy tailored to program goals (primary pediatric indication vs. follow on PIP/PSP)
- Protocol design – special attention to schedule of events, procedure burden, and age cohort segmentation
- Specialized safety monitoring
- Pediatrics clinical and operational expertise
- Site and PI selection – long-standing relationships with high quality pediatric sites
- Patient recruitment and retention
- Informed consent/parental assent
- IRB management
- Pediatric market evaluation and commercial strategy
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