Validation Studies

Accurate exposure and outcome definitions are foundational to real-world evidence.

Our team has been at the forefront of validation research for decades, with extensive experience designing and executing studies that ensure exposure and outcome measures are fit for purpose.

Our Approach

We design validation studies tailored to the research question, data source, and decision context. Our work emphasizes both scientific rigor and practical implementation within real-world data environments.

We conduct validation studies to support:

Diagnostic, procedure, and medication code and algorithm validation: Assessing the performance of claims and EHR based definitions

Algorithm development and refinement: Designing and iterating algorithms for specific outcomes

Medical record abstraction and adjudication: Structured chart review to establish gold-standard outcomes
Chart-confirmed endpoints for regulatory studies: Supporting studies where validated outcomes are required for decision-making
Quantitative bias analysis: Understanding tradeoffs and implications for study interpretation

Our approach ensures that:

▷ Outcome definitions are aligned with study objectives

▷ Validation is integrated efficiently within study workflows

▷ Results are interpretable and defensible in regulatory settings

Experience in Regulatory Contexts

We have extensive experience incorporating validation into studies designed to inform regulatory decisions, including safety and effectiveness evaluations.

This includes:

Designing validation strategies aligned with regulatory objectives
Supporting chart-confirmed endpoints for regulatory studies
Integrating validation within multi-site and distributed studies
Applying quantitative bias analysis to inform interpretation
Aligning outcome definitions with regulatory expectations
Developing transparent documentation for regulatory review

Validation in Distributed Data Environments

Our distributed data approach enables validation to be conducted at the level of the source data, where clinical context is preserved.

This allows for:

Access to medical records within partner systems
Collaboration with site investigators and clinicians
Scalable validation across diverse populations and care settings

Highlighted Publications and Study Protocols

‍Postmarketing safety surveillance for GSK's AS01ᴇ-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study.

Authors: Adimadhyam S, Luyts D, Oraichi D, Deraedt Q, Pircon JY, Bilker WB, Agan AA, Rajbhandari R, Carbonari DM, Djibo DA, Wang X, Nolan MB, DeVries A, Selvan M, Ma Q, Wentz AE, Daniels K, Platt R, Lo Re V 3rd, Cocoros NMAdimadhyam S, Luyts D, Oraichi D, Deraedt Q, Pircon JY, Bilker WB, Agan AA, Rajbhandari R, Carbonari DM, Djibo DA, Wang X, Nolan MB, DeVries A, Selvan M, Ma Q, Wentz AE, Daniels K, Platt R, Lo Re V 3rd, Cocoros NM

Published in BMJ Open on March 19, 2026

‍Validation of algorithms to detect acute and disseminated Lyme disease in U.S. administrative claims data

Authors: Kluberg SA, Cocoros NM, O'Neill J, Boyce TG, Sundaram ME, Schotthoefer A, Greenlee RT, Djibo DA, McMahill-Walraven CN, Aucott J, Moïsi JC, Jodar L, Willis SJ, Stark JHKluberg SA, Cocoros NM, O'Neill J, Boyce TG, Sundaram ME, Schotthoefer A, Greenlee RT, Djibo DA, McMahill-Walraven CN, Aucott J, Moïsi JC, Jodar L, Willis SJ, Stark JH

Published in Open Forum Infectious Diseases on February 20, 2025

Epidemiology of Guillain-Barré Syndrome and Risk Associated with Exposure to ABRYSVO Among Vaccinees 18-59 Years of Age in the United States

Harvard Pilgrim Health Care Institute, CVS Health, Carelon Research, HealthPartners Institute, Kaiser Permanente Southern California, 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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