There are specific needs and considerations associated with product development in the pediatric patient population, including the inclusion of patients and parents/guardians in the research study process, the critical focus on ensuring the safety and well-being of this vulnerable population, and the complex regulatory and commercial environment associated with children. These challenges demand that you partner with an experienced, multidisciplinary, cross-functional team that is passionate and focused on the needs of children and the development of therapies for them.
Our Pediatrics Consortium is well poised to develop and deliver specialized, fit-for-purpose solutions for your specific pediatric clinical research needs.
In the past five years, we have conducted:
- >284 projects in pediatric indications, including;
- >19 in hospital and ICU setting studies
- ~22% of our pediatric experience is also in the rare disease population
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)
Our Pediatrics Consortium: A Passionate Group of Experts
We have developed our Pediatrics Consortium out of the recognition that a cross-functional, passionate group of pediatric experts was needed to create and deliver tailored pediatric clinical and commercial development solutions to our customers who are focused on developing therapies for pediatric patients.
Within the Consortium are pediatricians, clinicians and therapeutic experts, pediatric regulatory consultants, pediatric site liaisons, biostatistics experts, and commercial strategists. This enables us to deliver end-to-end, creative solutions as your pediatric development partner.
With our cross-functional approach, we leverage our expertise and knowledge of pediatric disease and our database of patient location, availability and site quality, combining this with operational expertise to ensure an optimal, feasible and recruitable protocol.
Our regulatory and commercial consultants are well-versed in pediatric concerns, and we can ensure the appropriate data package is delivered to optimize regulatory probability of success as well as commercial return. 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
Partnering with our Pediatrics Consortium gives our customers access to a broad team of pediatric experts across clinical and commercial disciplines and enables the creation of efficient, innovative pediatric solutions and top-rate delivery of quality pediatric data and value to the customer.