Sentinel Operations Center (SOC)

Sentinel Operations Center (SOC)

The Sentinel Operations Center resides within the Harvard Pilgrim Health Care Institute. The Sentinel Operations Center works with the FDA to assess the risks and benefits of marketed medical products. 

Leadership

Jeffrey Brown portrait photo
Jeffrey Brown
Lead Data Scientist
Noelle Cocoros portrait photo
Noelle Cocoros
Lead Epidemiologist
Judith Maro portrait photo
Judith Maro
Operations Chief
Richard Platt portrait photo
Richard Platt
Principal Investigator
Darren Toh portrait photo
Darren Toh
Co-Investigator
Professional headshots by Elisif Photography

Harvard Pilgrim Health Care Institute leads the Sentinel Operations Center and collaboration with Sentinel’s 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 Sentinel Operations Center are to:

  • Enhance core data sources and evolve the Sentinel Common Data Model 
  • Develop novel distributed analytic tools
  • Further enhance capabilities in signal detection and other areas
  • Lead Real World Evidence demonstration projects through FDA-Catalyst

Below is how the Sentinel Operations Center answers the FDA's questions on marketed medical products

1. The Sentinel Operations Center works with the FDA to design studies that can get answers to the FDA’s questions.

 

The Sentinel Operations Center creates computer programs to conduct the studies. These programs use medical billing information and electronic health records from Data Partners. 

2. The Sentinel Operations Center sends these programs to the Data Partners, who run the programs on their own data.

 

Data Partners return the study results to the Sentinel Operations Center. They make sure to do this without revealing personal information from any patients. 

3. The Sentinel Operations Center combines the results into a single answer for FDA. The FDA uses this data, in conjunction with other information, to assess the risk or benefit of a marketed medical product.