Regulatory-Grade Solutions
Real-world evidence is part of regulatory decision-making, but how can you keep up?
For organizations engaged in clinical research and drug development, navigating the ever-evolving global regulatory landscape is more critical than ever. Regulatory agencies are poised to place greater emphasis on real-world evidence (RWE) for decision-making, while intensifying their scrutiny of real-world data (RWD) quality, methodologies, and processes.
At TriNetX, we empower organizations to meet these rigorous standards with confidence, keeping them ahead of the curve as regulatory landscapes evolve. Our expertise in robust evidence generation ensures trustworthy, data-backed insights to support well-informed decisions; enhances patient safety and monitoring; and accelerates access to life-changing therapies. Discover how we can help you thrive in this dynamic environment.
Unlock the Power of Pediatric Data with TriNetX
Dive into one of the world's most comprehensive, real-world data networks and enhance your research with high-quality, regulatory-grade datasets. Discover valuable insights into pediatric treatment patterns, safety signals, and health outcomes across the U.S. since 2010.
Download the TriNetX Pediatric Dataset now to elevate your clinical studies and contribute to groundbreaking scientific research.
Latest Regulatory Research
“Interplay of Spontaneous Reporting and Longitudinal Healthcare Databases for Signal Management: Position Statement from the Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance”
This publication highlights how combining spontaneous reporting databases with longitudinal healthcare data strengthens drug safety monitoring. By integrating these sources with advanced analytics, researchers can overcome individual limitations and improve pharmacovigilance outcomes.
“Healthcare claims-based Lyme disease case-finding algorithms in the United States: A systematic literature review”
“A Cohort Study to Evaluate the Real-World Utilization and Effectiveness of Bebtelovimab Compared to Nirmatrelvir/Ritonavir among Patients with Mild-to-Moderate COVID-19 Who Are at High Risk for Progressing to Severe Illness”
“Assessing the Robustness of Comparative Effectiveness Studies: An Applied Example Evaluating the Effectiveness of Bebtelovimab In COVID-19”
“Racial diversity and multimodal safety assessments: limitations of spontaneous reports data and the importance of advancing race-based risk stratification capabilities in real world data”
“Hyperkalemia Recurrence Following Medical Nutrition Therapy in Patients with Stage 3-4 Chronic Kidney Disease: The Revolutionize I Real-World Study”
“A Road Map for Peer Review of Real-World Evidence Studies on Safety and Effectiveness of Treatments”
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Our World-Renowned Experts
Jeff Brown
Chief Scientific Officer
K. Arnold Chan, MD, ScD, FISPE
Senior Vice-President, CSO Office
E. Susan Amirian, PhD
Senior Director, Research
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TriNetX is a global network of healthcare organizations and life science companies, driving real-world research to accelerate the development of life-saving therapies.
From trial operations to evidence generation, we put you at the forefront of discovery.
Clinical Trial Design & Optimization
Datasets & Analytics
Non-US Oncology
Real-World Evidence Generation
Pharmacovigilance & Drug Safety
Jeffrey Brown
Chief Scientific Officer
Jeffrey Brown, PhD 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, FISPE
Senior Vice-President, CSO Office
K. Arnold Chan, MD, ScD, FISPE, is an internationally recognized epidemiologist with more than 30 years of global research experience in academia and the private sector, primarily in the post-marketing evaluation of pharmaceutical agents and vaccines. He has served on the Harvard School of Public Health and National Taiwan University faculty and was Chief Scientist of the epidemiology unit of a Fortune 10 company. Dr. Chan has authored or co-authored more than 150 peer-reviewed articles on pharmacoepidemiology and clinical epidemiology and co-edited a textbook on pharmacoepidemiology and therapeutic risk management.
E. Susan Amirian, PhD
Senior Director, Research
A seasoned MD Anderson-trained epidemiologist with over 15 years of observational research experience, Dr. Amirian has previously led teams on sponsored real-world research projects at small startups and a Fortune 10 company, where she drove impactful insights from real-world data. She also led the Public Health Portfolio at the Texas Policy Lab, Rice University, focusing on innovative public health initiatives. Before this, she was an Assistant Professor in the Division of Hematology-Oncology at Baylor College of Medicine and was the Associate Director of Data Quality at the Population Sciences Biorepository. Her expertise spans epidemiology, oncology, and data quality management, contributing significantly to advancing medical research and healthcare practices.
