PREGNANCY STUDIES
Pregnancy Study Designs
Robust, regulatory grade, real world evidence generation to assess pregnancy and infant outcomes after in-utero drug exposure
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn moreDeveloping IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn moreDeveloping IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn moreDeveloping IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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SEARCH JOBSRobust, regulatory grade, real world evidence generation to assess pregnancy and infant outcomes after in-utero drug exposure
Detects and records:
Descriptive safety study that collects prospective and retrospective data in women exposed to the medicinal product of interest during pregnancy and/or lactation to assess:
A pregnancy study using existing data (e.g. medical records, claims, registry data) for women exposed to the medicinal product of interest during pregnancy compared to an unexposed control population
Assesses:
PK study to assess concentrations of the medicinal product of interest in breast milk and or infant plasma, as well as reported adverse effects on the breastfed infant.
As pregnant women are still largely excluded from clinical development programs, intending and expecting mothers and their health care providers need real world evidence to decide if their treatment benefits outweigh long term risks of in-utero exposure for their child.
Several study designs have been established and frequently required by regulators to generate this evidence. See the drop-down menu to learn more.
Real world evidence generated by pregnancy studies helps patients and providers make important treatment decisions. Organizations can partner with IQVIA to design meaningful studies using RWE while meeting regulatory requirements to evaluate safety.
IQVIA’s team of epidemiologists, biostatisticians, data managers, nurses, and project managers offer extensive experience designing, implementing and managing pregnancy studies – all with the patient in mind.
A patient-focused virtual design for primary data collection studies (registry, surveillance and lactation) helps manage costs while remaining sensitive to women’s journeys during a major life event.
Consistent interaction with the FDA and EMA for protocol, statistical analysis plans (SAPs), and interim and final study reports ensure valid real world evidence for regulators.
Specialized direct-to-patient technology supports all aspects of the patient journey, from enrollment to data collection, helping to retain women and new mothers in important studies.