Health Data Collaborations for Safety and Effectiveness Research (HDC-SER)

Best-in-class expertise in complex multi-site leadership and operations

The Health Data Collaborations for Safety and Effectiveness Research (HDC-SER) program leverages the FDA Sentinel Initiative’s national medical product monitoring system to conduct public health and safety surveillance for pharmaceutical, biologic, and medical device manufacturers.

Providing expertise in complex multi-site leadership and operations, the team implements methodologies informed by our decades of expertise in distributed research networks (DRNs). We work with partners to develop and execute a range of studies to meet our sponsors’ business, regulatory, and scientific needs. These include:  

  • Postmarketing Requirement (PMR) & Postmarketing Commitment (PMC) Studies
  • Risk Evaluation and Mitigation Strategy (REMS) Evaluations
  • Validation Studies
  • Comparative Effectiveness Studies
  • Pragmatic Clinical Trials (PCTs)   
  • Direct-to-Patient Studies

HDC-SER's specialized team also offers expert consulting and training.

We serve as a coordinating center for scientific, operational, and analytic leadership. Our relationships with an established network of Research Partners with both scientific expertise and curated claims and other data uniquely positions our team to lead and conduct studies leveraging the network’s resources. We have extensive experience creating, managing, and operating secure distributed networks for multi-site, national research supporting drug and vaccine safety surveillance; monitoring drug exposure/uptake and safety and effectiveness outcomes; regulatory decision making; and effectiveness research at a scale far greater than standard methodologies enable.