Satisfying Your Postmarketing Commitment to the FDA
Excellence in Pregnancy Exposure Registries
The Center for Better Beginnings has been helping pharmaceutical companies fulfill post marketing requirements for pregnancy registries for over 15 years. Led by Dr. Tina Chambers, a perinatal epidemiologist and expert on the study of medication and vaccine exposures in pregnancy, via our MotherToBaby Pregnancy Studies program we can offer you:
- The power of a rigorously designed cohort study that includes exposed, disease control (where applicable), and non-exposed pregnancies.
- A proven protocol for marketing and recruitment of eligible pregnancies.
- An established partnership to receive referrals from MotherToBaby teratogen information services located 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.
To Learn More, Contact Our Pregnancy Registry Experts Today!
MotherToBaby Pregnancy Studies are conducted by the Organization of Teratology Information Specialists (OTIS) and coordinated at the Center for Better Beginnings, located in the University of California San Diego Department of Pediatrics.