Multi-Site Methods and Coordination

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Our Approach

We design and lead multi-site studies that generate rigorous real-world evidence on the safety, effectiveness, and use of medical products.

Our multi-site work is grounded in a distributed data model, where analytic programs are developed centrally and executed locally within partner dataenvironments.

This approach enables:

Standardized analytics across sites while preserving local data control
Direct engagement with data partners, including access to clinical expertise and source data context
Scalable study execution across care settings

The Distributed Data Advantage

Distributed data networks offer advantages beyond traditional common protocol approaches and centralized data models.

Compared with site-by-site implementation using a common protocol:

Improved consistency through centrally developed analytic programs
Reduced variability in implementation across sites
More efficient quality assurance and reproducibility

Compared with centralized data aggregation:

Data remain within source environments, supporting privacy, governance, and stewardship
Enhanced flexibility to include partners who cannot share patient-level data externally
Ability to validate outcomes and algorithms through site-level access

Together, these features enable large-scale research with scientific rigor and operational efficiency.

Quality Assurance

Data quality is as critical as study design. We work closely with data partners to ensure that underlying data are fit for purpose, through:

Data curation and harmonization across sites
Systematic data quality assessment and documentation
Standardized analytic pipelines with embedded checks
Transparent, reproducible workflows

This approach ensures that evidence generated across sites is valid, consistent, and reliable.

Sentinel Initiative Methods

Many of the methods used in our multi-site studies have been developed and refined through our leadership of the Sentinel Initiative, a national distributed data network established by the U.S. Food and Drug Administration to monitor the safety of medical products.

The Sentinel System has helped advance methods for distributed data analysis, active safety surveillance, and large-scale observational studies using healthcare data. These methodological foundations inform the design and execution of many of the multi-site studies conducted by our team.

‍About Sentinel methods and infrastructure

Highlighted Publications and Study Protocols

Post-Authorization Safety Study to Assess the Risk of Diabetic Ketoacidosis Among Type 2 Diabetes Mellitus Patients Treated with Ertugliflozin

‍Authors: Rai A, Marshall J, Nandyala S, Her M, Agan AA, Huang TY, Rodriguez-Watson C, Clary A, Diessner B, Nolan MB, Djibo DA, DeVries A, Daniels K, Zhang X, Wang T, Gantz I, Shankar R, Zale MM, Ejelonu P, Frederich R, Masiukiewicz U, Toh S

Published in Diabetic Medicine on December 15, 2025

Interim Safety of RSVpreF Vaccination During Pregnancy

Authors: Michnick AI, MacDonald SC, Cosgrove A, Adimadhyam S, Zhang F, Petrone AB, Round KE, Gandhi S, Koram N, Anastasiou OE, Rubino H, Lino MM, Djibo DA, Kuntz JL, Love SM, McMahill-Walraven CN, Palmsten K, Wentz AE, Maro JC, Platt R

Published in Journal of the American Medical Association (JAMA) on February 3, 2026 ‍