Regulatory Studies

Proven leadership for high-stakes regulatory research

We design and conduct real-world evidence studies to support regulatory decision-making across the product lifecycle.

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.

What Makes Our Experience Unique

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

What We Do

Post-approval safety studies (PASS): 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

Highlighted 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.

We bring the experience, infrastructure, and scientific expertise required to generate real-world evidence for regulatory decision-making.

Read our publications