Pregnancy Registries and Infant Follow-up Studies
PPD is a leading global provider of pregnancy registries and other study methodologies to assess the effects of exposure to medicinal products during pregnancy. We provide consultation, design, implementation, analysis, interpretation and dissemination services, including:
- Pregnancy exposure and infant follow-up studies
- Case control studies
- Database studies (linked medication, obstetric and pediatric data)
- Study design and protocol services as well as services to develop case report forms
- Negotiations with regulatory agencies
- Establishment and facilitation of advisory committees
- Registry/study implementation and project management
- Awareness strategies to aid recruitment and retention
- Endpoint evaluation, adjudication and signal detection
- Study reports, scientific manuscripts and abstracts
Extensive Experience in Pregnancy Studies
Studies that evaluate the safety of medicinal products when used during pregnancy face unique challenges, such as achieving an adequate sample size, limited data availability, multiple data sources and identification of appropriate comparator groups. PPD overcomes these challenges successfully by having:
- More than 14 years of experience working with clients to develop and implement pregnancy studies that meet regulatory agency requirements in a wide range of therapeutic areas
- Experienced staff that includes perinatal nurses, board-certified obstetricians and perinatal epidemiologists
- Thought leaders who have served as invited consultants to the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control (CDC) and who have published or presented more than 50 papers on best practices concerning pregnancy registries
Global Presence
Efforts to monitor the effects of drug exposure in pregnancy are an important part of responsible drug safety management. The demand for pregnancy registries and other study methodologies is expected to increase globally as regulatory authorities continue to require these studies as post-approval commitments. PPD’s presence in developed and emerging markets and ability to provide the full spectrum of pregnancy-exposure and infant follow-up services help clients meet their objectives.
