We Can Help You Satisfy Your Post-Marketing Commitment to the FDA
MotherToBaby, a service of the non-profit Organization of Teratology Information Specialists (OTIS), is the nation’s leading authority and most trusted source of evidence-based information on the safety of medications and other exposures during pregnancy and while breastfeeding. We have also been helping pharmaceutical companies fulfill their post-marketing requirements for pregnancy registries for over 15 years.
Led by Dr. Tina Chambers, a world-renowned perinatal epidemiologist at the University of California San Diego and an expert on the study of medication and vaccine exposures in pregnancy, our MotherToBaby Pregnancy Studies program can offer you:
- The power of a rigorously designed cohort study that includes exposed, disease control (where applicable), and non-exposed pregnancies.
- An established protocol for marketing and recruitment of eligible pregnancies.
- Partnership with MotherToBaby’s teratogen information services to receive referrals from across North America.
- Standardized methods for data collection, review of obstetric and pediatric medical records, and SAE reporting.
- A North America-wide team of expert pediatricians who conduct in-person physical examinations of live-born children.
- The opportunity to evaluate short- and long-term pediatric outcomes.
- Cutting-edge analytic methods and reporting.
MotherToBaby Pregnancy Studies are conducted by OTIS and coordinated at the Center for Better Beginnings, located in the University of California San Diego Department of Pediatrics.