PREGNANCY STUDIES

Pregnancy Study Designs

Robust, regulatory grade, real world evidence generation to assess pregnancy and infant outcomes after in-utero drug exposure

PREGNANCY STUDIES

Pregnancy study designs and Real World Evidence

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.

   

The Right Partner for Pregnancy Studies

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.

The Right Partner for Pregnancy Studies

Create and implement impactful pregnancy studies

Experience and expertise

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-centric approach

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.

Scientifically robust real world evidence

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.

Direct-to-Patient Technologies

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.

Contact Us