Database Studies

Secondary research using databases presents both opportunities and limitations. Because we are “database agnostic” and have experience working with over 40 different data sources, we understand the complexities and issues of working with these datasets. We can help you determine if it is feasible and effective to use existing data sources, and if so, which data source(s) would best answer your health economic, regulatory real-world evidence, epidemiology, and/or drug safety questions.

Our experts have conducted database studies for pharmaceutical clients at the request of the US FDA, EMA, and other national agencies in North America, Europe, and the Asian Pacific region. In addition, our experts have conducted studies funded by the EMA and the US FDA.

New Tools Generate Transparent and Reproducible Real-World Evidence from Diverse Data Sources

The Power of Database Studies

Database research can help you gain insights on:

  • Medication, device, vaccine, and other treatment safety profiles
  • Disease prevalence and public health impact
  • Event rates
  • Patient characteristics
  • Burden of illness
  • Treatment patterns and drug utilization
  • Medication adherence and persistence
  • Comparative effectiveness and value of alternative treatments
  • Validity of electronic database information to identify specific disease endpoints

State-of-the-Art Research Methods

Our advantage lies in our research team and the scientific rigor they bring to your projects so you can confidently make good decisions based on your study’s results. Our process includes: 

  • determining the appropriate analytical methods, including
    • case-control
    • cohort analyses
    • pre-post analyses
  • preparing study protocols
  • accessing and extracting data
  • developing statistical analysis plans and outcomes measures

As needed, we employ advanced statistical techniques such as:

  • propensity scoring to control for selection bias
  • Kaplan-Meier techniques to summarize time-based outcomes
  • Poisson and Cox proportional hazard models for multivariable analyses
  • generalized linear models to assess cost-related outcomes
     

Speed, Accuracy, Trust

Generating Real-World Evidence with the BEKhealth Network

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Coordinating Center for Studies Using Multiple Databases

Increasingly, RWE studies require a sample size exceeding that available from a single database and experience in patient populations across multiple countries—and if you have such a need, we can help. Our project experience includes serving as a coordinating center for studies that utilize multiple research partners and databases. For example, we coordinated research across 11 US databases using a data model based on the US Sentinel Network project. We are part of the VAC4EU and SIGMA research consortia. Other multi-database projects can be found among studies in the HMA-EMA Catalogue of RWD Studies.

Featured Publications

Kawai AT, Fuller CC, Hawrusik R, Iyer GS, Koram N, Agan AA, Alam S, Avula R, Brown JS, Burk J, Connolly JG, Daniels K, DeFor T, DeVries A, Diessner BJ, Djibo DA, Ezzy S, Cai B, Layton JB, Dea K, Tetreault-Langlois P, Lyons JG, Love SAM, Mayer SE, Ma Q, McMahill-Walraven CN, Nolan MB, Oyedele N, Peters A, Reynolds JS, Taggert E, Wideman K, Ziyadeh NJ, Gilsenan AW, Platt R. Risk of myocarditis/pericarditis after receipt of Pfizer-BioNTech COVID-19 vaccine: results from a post-approval safety study in the US. Presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.

Meet Our Experts