Regulatory Studies

Our Approach

Our work reflects more than four decades of leadership in regulatory science, including leading the FDA Sentinel Initiative since its inception in 2009.

This experience has shaped how we approach study design, data, and methods. Our regulatory research is scientifically rigorous and aligned with the expectations of regulatory decision-makers.

We emphasize:

Fit-for-purpose data selection aligned with the regulatory question
Rigorous data quality assessment and documentation
Adherence to rigor and reproducibility principles

This approach ensures that evidence is not only robust—but credible in regulatory contexts.

What We Do

Post-authorisation safety studies (PASS), PMC and PMR: Evaluating risks in real-world populations

Comparative safety and effectiveness analyses: Informing treatment decisions and regulatory considerations

Validation and endpoint development: Ensuring outcomes are fit for regulatory use

Signal detection and evaluation: Identifying and assessing potential safety signals

Studies in special populations: Including pregnancy, pediatrics, and older adults

Label expansion and population-specific studies: Generating evidence in underrepresented or high-priority groups

What Makes Our Experience Unique

Regulatory decisions require confidence in the underlying data and methods.

We emphasize:

Over 40 years of regulatory research experience: Continuous engagement with regulatory partners since the mid-1980s
Leadership of the FDA Sentinel Initiative: Designing, building, and operating one of the largest active surveillance systems in the world
Integration of science and execution: Aligning advanced epidemiologic methods with practical study delivery
Proven multi-site infrastructure: Coordinating large-scale distributed studies across diverse data partners
Methods developed for regulatory applications: Including signal detection, sequential monitoring, and validation frameworks

Highlighted Publications and Study Protocols

A Targeted Safety Study, EPI-ZOSTER-030 VS US DB, to Evaluate the Safety of Shingrix in Adults ≥ 50 Years of Age in the United States

Harvard Pilgrim Health Care Institute, CVS Health, Carelon Research, Humana HealthCare, Optum Epidemiology, GlaxoSmithKline

A Rapid Surveillance and Cohort Post-Marketing Safety Study to Evaluate the Safety of Respiratory Syncytial Virus Vaccine (ABRYSVO™) Exposure During Pregnancy in the United States

Harvard Pilgrim Health Care Institute, CVS Health, Carelon Research, HealthPartners Institute, Kaiser Permanente Northwest, Pfizer, Inc.

Explore Publications

Explore our full publication library to learn more about the studies and methods that inform our work.
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publications

Regulatory Research & Support