Summary
There are two distinct centers within the Sentinel Initiative:
These centers collaborate to advance regulatory science using the Sentinel System. Each center operates independently and has a dedicated leadership team with dedicated staff.
Sentinel Innovation Center (IC)
The IC is led by four Lead Hubs in collaboration with Harvard Pilgrim Health Care Institute:
- Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, and Harvard Medical School
- Duke Clinical Research Institute
- Vanderbilt University Medical Center Department of Biomedical Informatics
- Kaiser Permanente Washington Health Research Institute & University of Washington School of Public Health
This center focuses on developing innovative methods to further advance Sentinel. This includes exploring ways to extract and structure information from electronic health records. The primary functions of the Innovation Center are to:
- Improve capabilities of Sentinel by leveraging new data sources
- Build tools needed to enable Sentinel queries to include electronic health record data
- Enhance real-world evidence capabilities through advanced analytics
Learn more about the IC.
Sentinel Operations Center (SOC)
Harvard Pilgrim leads the SOC and its Data Partners, using a distributed database. This center leverages organizational partnerships in the areas of:
- Epidemiology
- Clinical medicine
- Pharmacy
- Statistics
- Health informatics
- Data science (specifically, artificial intelligence tools like natural language processing and machine learning)
- Network operations to support post market safety analyses.
The primary functions of the SOC are to:
- Enhance core data sources and evolve the Sentinel Common Data Model
- Develop novel distributed analysis tools
- Further enhance capabilities in signal detection and other areas
- Lead Real World Evidence demonstration projects through FDA-Catalyst