Meet the Leading Experts in Real-World Evidence Generation
From clinical development to market access, give your next critical mission the benefit of our world-renowned experience.
Mission control for mission-critical real-world evidence
Led by Jeffrey Brown, PhD, and K. Arnold Chan, MD, ScD, our RWE consulting team exists to achieve your goals, no matter your leg of the evidence generation journey. Whether you’re revising your protocol or fulfilling a post-marketing requirement, let us help you move forward with the speed and confidence that only decades of clinical and regulatory experience can provide.
World-Renowned Real-World Evidence Experience
There’s no space our experts haven’t traveled in their years working with or for the FDA, renowned universities, and hundreds of the world’s most innovative drug developers. Below is partial list of their specialties.
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R&D and Clinical Development
- Synthetic Control Arms
- Natural History Studies
- Background Rates
- Burden of Illness
- Unmet Need
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Regulatory
- Pre-submission Data Generation
- Post-marketing Requirements
- Safety and Pharmacovigilance
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HEOR, Commercial, and Market Access
- Outcome Validation Studies
- Comparative Safety and Effectiveness
- Budgetary Models
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Services from protocol through dissemination
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Thought Leadership for RWE, RWD, Pharmacoepidemiology, and Regulatory Strategy
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Data Source and Methods Consultation
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Design and Conduct Analyses
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Study Protocol and SAP Development
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Scientific Dissemination (abstracts, manuscripts, etc.)
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Natural Language Processing (NLP)
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Chart Reviews
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Meet the Real-World Evidence Team
Jeff Brown, PhD
Chief Scientific Officer
Jeffrey Brown, Ph.D., is an internationally recognized expert in the use of real-world data to support the evidentiary needs of regulatory agencies and medical product sponsors and an expert in the assessment of data quality of real-world data resources. Dr. Brown has more than 25 years of experience in research using real-world data, most recently as an Associate Professor in the Department of Population Medicine at Harvard Medical School and as a trusted consultant to numerous research groups and pharma companies. Dr. Brown holds a master’s degree in Economics from Tufts University and a PhD in Social Policy from Brandeis University.
K. Arnold Chan, MD, ScD
Senior Vice-President, Insights and Evidence Generation
K. Arnold Chan, MD, ScD is an internationally recognized physician epidemiologist with more than 30 years of global research experience in academia and the private sector, primarily on evaluation of pharmaceutical agents and vaccines. He has served on the faculty at National Taiwan University and Harvard School of Public Health. He has extensive experience in managing research organizations and complex human research projects. In addition to scientific research, he has provided consulting input to Taiwan Food and Drug Administration and related health authorities for more than 20 years. Dr. Chan has authored or co-authored more than 150 peer-reviewed articles on pharmacoepidemiology and clinical epidemiology, and co-edited one of the two most widely used English textbook on pharmacoepidemiology.
Launching with the right data
No two projects require the same data. After helping you frame your question or formalize your goal, our consultants will interrogate our global network of EHR data for just the right cohort. For longitudinal studies or value-based questions, where continuity and costs are paramount, we’ll turn to our growing dataset of EHR-linked claims data. If gaps remain, we’ll propose a chart review or a third-party data license.
Whatever the trajectory, we remain laser-focused on the alignment of objectives, methods, and data.
The TriNetX Difference
Transforming data into fit-for-purpose evidence isn’t just a statistical process. It takes the the right people—experts who’ve faced the challenges you’re facing now, and solved them—to source and curate the right data at the start. It takes an array of ultra-capable products to mine and model billions of values. Finally, it takes partnerships with healthcare institutions around the world, for chart reviews and clinical thought leadership.
TriNetX has the people, products, and partnerships needed to advance your next project.
TriNetX Real-World Evidence Publications
Below is a small sample of the results our team has delivered. Curious to know if they’ve done work related to your goals? Chances are excellent they have. Get in touch through the form below and we’ll direct you to relevant examples.
Validation of diagnosis codes to identify hospitalized COVID-19 patients in health care claims data
Kluberg SA, Hou L, Dutcher SK, Billings M, Kit B, Toh S, Dublin S, Haynes K, Kline A, Maiyani M, Pawloski PA, Watson ES, Cocoros NM. Validation of diagnosis codes to identify hospitalized COVID-19 patients in health care claims data. Pharmacoepidemiol Drug Saf. 2022 Apr;31(4):476-480. doi: 10.1002/pds.5401. Epub 2022 Jan 3. PMID: 34913208.
ADHD Drugs and Serious Cardiovascular Events in Children and Young Adults
Cooper WO, Habel LA, Sox CM, Chan KA, Arbogast PG, Cheetham TC, Murray KT, Quinn VP, Stein CM, Callahan ST, Fireman BH, Fish FA, Kirshner HS, O’Duffy A, Connell FA, Ray WA. ADHD drugs and serious cardiovascular events in children and young adults. N Engl J Med. 2011 Nov 17;365(20):1896-904. doi: 10.1056/NEJMoa1110212. Epub 2011 Nov 1. PMID: 22043968; PMCID: PMC4943074.
Algorithms for identification of Guillain-Barré Syndrome among adolescents in claims databases
Funch D, Holick C, Velentgas P, Clifford R, Wahl PM, McMahill-Walraven C, Gladowski P, Platt R, Amato A, Chan KA. Algorithms for identification of Guillain-Barré Syndrome among adolescents in claims databases. Vaccine. 2013 Apr 12;31(16):2075-9. doi: 10.1016/j.vaccine.2013.02.009. Epub 2013 Mar 6. PMID: 23474311.
Put us to the test
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