Sentinel Operations Center (SOC)

Summary

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

How the Sentinel Operations Center Assesses the Risks and Benefits of Marketed Medical Products

Below is how the SOC answers the FDA's questions on marketed medical products.

1. The SOC works with FDA to design studies that can get answers to FDA’s questions.

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

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

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

3. The SOC combines the results into a single answer for FDA.

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