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, the complex regulatory and commercial environment associated with children and the fact that the pediatric population is not unique, rather consists of several age groups with different physiological features and development stages. 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:
- >270 pediatric projects and consultancy agreements, enrolling over 100,000 pediatric patients and working with over 10,000 sites.
- We have experience running clinical trials across all study phases and regions from complex phase I PK / PD studies until late phase trials.
Our experience crosses all therapeutic areas, including but not limited to:
- Endocrinology / Metabolism
- Immunology and Inflammatory
- Infectious Disease
- Respiratory and Allergy
- Skeletal Diseases
Our Pediatrics Consortium: A Passionate Group of Experts
We have developed our Pediatrics Consortium as a global and cross functional platform, consisting of people experienced in different fields of pediatric clinical and commercial drug development solutions. Within the Consortium are pediatricians, clinicians, study nurses and other therapeutic experts, pediatric regulatory consultants, site liaisons, medical writers, biostatisticians and rare disease experts, as well as 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 and high data quality.
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:
- Pediatric regulatory guidance and regulatory services for FDA/EMA
- Program/plan development & writing
- Modeling & Simulation
- Study summary/protocol design & writing
- Informed consent & assent forms
- Pediatric site identification
- Organization & management of DSMC
- Pediatric medical consultancy
- Medical monitoring by Pediatricians
- Patient enrollment & retention documents & strategies for each pediatric age group
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.