Maternal and Child Health

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.

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