Our Real-World Evidence Practice leads both applied and methodologic research on the safety, effectiveness, and utilization of drugs and vaccines using large healthcare data sources and longstanding multi-site research collaborations.
Our Mission is to provide quality pharmacoepidemiology research for industry collaborators to advance public health research.
Our vision is to expand the scope of our work and partnerships by:
Our work spans nearly four decades and has contributed to the development of modern pharmacoepidemiology and distributed data networkresearch.
Our investigators began collaborating with the U.S. Foodand Drug Administration (FDA) in the mid-1980s, supporting early efforts to evaluate drug safety and risk management strategies using large healthcare datasources.
These efforts helped establish foundational approaches to:
During this period, our researchers played a central role in developing multi-institutional research networks to study the safety and effectiveness of therapeutics across large populations.
This work included:
Our research supported:
In 2009, we established the Coordinating Center for the Sentinel Initiative, a national distributed data network developed by the FDA to actively monitor the safety of regulated medical products.
Through our stewardship, the program:
In parallel, our work has advanced:
We work with life sciences organizations to design and conduct rigorous pharmacoepidemiologic studies addressing regulatory commitments, safety surveillance, comparative effectiveness, validation, and real-world utilization of medical products.
