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 registries and infant follow-up studies
• Case control studies
• Database studies (linked medication, obstetric and pediatric data)
• Study design, protocol and case report form development services
• Negotiations with regulatory agencies
• Establishment and facilitation of advisory committees
• Registry/study implementation and project management
• Recruitment and retention plans
• Signal detection, endpoint evaluation and adjudication
• 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 through our:

• Experience developing and implementing pregnancy studies that meet regulatory agency requirements in a wide range of therapeutic areas since 1997
• Experienced staff, including perinatal nurses, board-certified obstetricians and perinatal epidemiologists
• Thought leaders who have served as invited consultants to the World Health Organization, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) and who have published or presented more than 50 papers on best practices concerning pregnancy registries