Single and Multi-Database Post-Authorization Safety Studies
We have extensive experience working with data partners and regulators to design and efficiently manage large studies to meet regulatory requirements on time and on budget. New drugs often require multiple databases to study events that require hands-on familiarity with automated data. We provide database expertise with medical claims, pharmacy claims, and laboratory results in collaboration with healthcare providers to ensure the validity and quality of the data. Scientific expertise integrating and harmonizing diverse data types and sources gives us an unparalleled understanding of the nuances of automated data assets.