We know the unique challenges clinical studies of maternal and pediatric populations present
We understand the physiological and ethical reasons for these challenges, and the diverse and discrete issues, and we are skilled in the nuances of this patient group. So our solutions in study design and implementation deliver high quality results acceptable to regulatory agencies and prominent journals.
Ravinder Anand, Ph.D.
Having a CRO with extensive experience specifically in the maternal health and pediatric domain can give you greater confidence in your clinical trials and resulting data and also ensures that your study
protocols, data, site monitoring plans, and statistical analyses are designed to address things such as:
- Compliance issues in adolescents
- Neonates hospitalized populations in tertiary care units
- Parental involvement
- 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, we have supported approximately 80 regulatory
submissions per year. That includes 39 INDs, 11 PINDs and 14 label changes across a variety of therapeutic areas and indications.
By collaborating with organizations that share our mission to advance public health and biopharmaceutical innovation, we’ve been instrumental in generating ground breaking insights that advance the understanding of neonatal and pediatric medicine. For example, Emmes provides full service support to a biopharma funded study for non-opioid treatment of neonatal opioid withdrawal syndrome which currently does not have a FDA-approved pharmacotherapy treatment.
Additionally, our 15 year partnership with NICHD has enabled us to take part in multi-protocol epidemiological observational studies examining fetal growth, gestational diabetes, asthma, air pollution and other environmental exposures on maternal and child health.
Emmes has contributed to the field of adherence research in adolescents and young adults (AYA). We have worked with transplant physicians and behavioural scientists to help develop and validate
biomarkers for adherence to immunosuppressive medications. We recently embarked on a new program designed to help increase uptake and adherence to PrEP and ART for AYA at risk for or diagnosed with HIV.
Experience and Expertise
Types of Studies
- Pharmacokinetic/pharmacodynamic safety and efficacy
- Phase I-III
- Post-marketing/Phase IV
- Epidemiological
- Adherence
- Device
- RWD/RWE
Therapeutic Areas
- Psychiatry, cardiovascular, anti-infectives, anti-viral, pulmonary, metabolism, endocrinology, neurology, liver and kidney transplant, immunology, infectious diseases, rare diseases, pediatric vaccines, and neonatal opioid withdrawal syndrome.
Patient Populations
- Pregnant and lactating mothers
- Pre-term and term neonates
- Infants
- Toddlers
- Early and middle childhood
- Adolescents
- Hard to enroll patients such as non-adherent and patients from low economic status
Services for Clinical Research in Maternal and Child Health
- Statistical leadership, reporting and analysis
- Development of study materials (protocol, ICF/Assent template, manual of procedures, study logs, CRFs, instruction manuals, training materials)
- Advantage clinical data platform featuring one unified platform for
- eCRF, ePRO, IWRS and IP Tracking
- TeleVisits
- Specimen and image tracking and management
- Site selection, management, monitoring and training
- Study administration and management
- Data management and bespoke data solutions
- Pharmacovigilance
- 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
Open communication between our therapeutic area leaders and your team is key to success. Get in touch to discuss your plan for maternal and/or pediatric trials and how we can support your development pathway.
