Pediatric Vaccine Trials
Conducting clinical studies in maternal and pediatric patient populations involves unique challenges, introduced due to physiological and ethical reasons. The diverse and discrete set of issues across age groups creates a level of complexity that is best served by a CRO partner skilled in the nuances of this patient population – one that can provide you with solutions in study design and implementation resulting in high quality data acceptable to regulatory agencies and prominent journals. Our expertise includes pediatric vaccine trials, as well as a wide range of other maternal and pediatric clinical trials for FDA approval.
Having a CRO with extensive experience specifically in the pediatric domain can give you greater confidence in data from pediatric clinical trials and also ensure that your study protocols, data collection, site monitoring, and statistical analysis plans are designed to address things such as compliance issues in adolescents; neonates and hospitalized populations in tertiary care units; parental involvement; adverse events; suicide risks in adolescent psychiatric studies; recruitment issues associated with the scarcity of eligible patients; working with preverbal or nonverbal children, and so much more.
As the Data Coordinating Center for the National Institute of Child and Human Development’s (NICHD) Best Pharmaceuticals for Children Act (BPCA) program, Emmes has supported 125 regulatory submissions per year including 40 INDs and 11 label changes across a variety of therapeutic areas and indications. We possess specialized pediatric clinical research expertise in kidney and liver transplant research, epilepsy, and studies involving opioid use in pregnant and lactating mothers.
Through our collaboration with other organizations whose missions involve improving public health, Emmes has been instrumental in generating groundbreaking insights that advance the understanding of neonatal and pediatric medicine. Our engagement with NICHD for over 15 years, for example, has enabled us to participate in multi-protocol epidemiological observational studies examining fetal growth, gestational diabetes, asthma, air pollution and other environmental exposures on maternal and child health.
Experience and Expertise
Types of Studies
- Pharmacokinetic/pharmacodynamic safety and efficacy
- Phase I-III
- Post-marketing/Phase IV
- Psychiatry, cardiovascular, anti-infectives, anti-viral, pulmonary, metabolism, Endocrinology, neurology, liver and kidney transplant, immunology
- Pregnant and lactating mothers
- Pre-term and term neonates
- Early and middle childhood
- Hard to enroll patients such as non-adherent and patients from low economic status
Services for Clinical Research in Pediatrics
- Statistical leadership, reporting and analysis
- Development of study materials (protocol, ICF/Assent template, manual of procedures, study logs, CRFs, instruction manuals, training materials)
- Electronic data capture via Advantage eClinical
- eCRF, ePRO, IWRS and IP Tracking
- Specimen and image tracking and management
- Site selection, management, monitoring and training
- Study administration and management
- Data management and bespoke data solutions
- Real world data/Real world evidence
- Global regulatory support
- Customized apps for remote data capture
- Centralized cloud-based repository with expert review of images, biopsies,sonography, etc. including those maintained within a PACS system
Maternal and Child Health Leaders
At Emmes, we value the open exchange of communication between our therapeutic area leaders and your team. We encourage you to contact us to discuss your plan for pediatric trials and determine how we can support your development pathway.