Influential Women Showcases Cynthia J. Girman, DrPH, FISPE: Global Leader In Real-World Evidence And Patient Outcomes
Cynthia J. Girman is an internationally recognized leader in pharmacoepidemiology, real-world evidence (RWE), and patient outcomes research, with more than 45 years of experience shaping how real-world clinical evidence is generated, interpreted, and applied. Throughout her distinguished career, she has focused on the design and execution of randomized clinical trials and observational studies, with particular emphasis on advancing methodological rigor, strengthening study design, and generating fit-for-purpose evidence that informs healthcare, regulatory, and payer decision-making. Today, her work has expanded beyond the pharmaceutical and biotech consulting world. As founder of BeatSUD Foundation, Inc., she is building a new ecosystem of rigorous clinical evidence in substance use disorders and brain disorders, research that she believes may support integration of new tools into clinical practices.
Her work has played a role in shaping how clinical endpoints and patient-reported outcomes (PROs) are developed and validated, helping bridge the gap between traditional clinical research and real-world application. Through her contributions, Cynthia has helped ensure that evidence generated in research settings more accurately reflects patient experiences, treatment effectiveness, and long-term health outcomes in real-world clinical practice.
Cynthia is the Founder and Chief Executive Officer of CERobs Consulting LLC, a global consulting organization she established in early 2015. Through CERobs, she has built a highly collaborative, international network of expert consultants in biostatistics, epidemiology, medical writing, and health economics outcomes research (HEOR). The organization operates on a non-hierarchical, flexible, and remote-first model, allowing part-time, highly experienced experts across disciplines and geographies to collaborate on pharmaceutical and healthcare consulting projects. This structure reflects her belief that scientific excellence is strengthened through shared expertise, mutual respect, and interdisciplinary collaboration rather than traditional organizational hierarchies.
Before founding her consulting firm, Cynthia dedicated more than three decades to Merck & Co., Inc., where she worked with others to lead epidemiology, observational research, patient-reported outcomes development and validation, and data analytics initiatives. In that role, she was instrumental in developing strategies for integrating RWE and patient outcomes into drug development and regulatory submissions.
In addition to her industry leadership, Cynthia has played a significant role in shaping global research standards through her service on the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI), where she served for 11 years. She is also an Adjunct Professor of Epidemiology at the University of North Carolina at Chapel Hill and an elected Fellow and former Board member of the International Society of Pharmacoepidemiology. Across these roles, she has consistently contributed to strengthening research methodology, fostering collaboration, and mentoring the next generation of scientific leaders.
Cynthia is co-editor of the 2021 Elsevier Sciences publication titled Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic in the field of clinical and real-world research methodology.
She is an award-winning co-author of the book A Voice from Heaven, written with her late son, Alexander V. Girman, a collaboration that holds deep personal meaning in her life and work (www.avoicefromheaven.com).
In 2024, Cynthia founded BeatSUD Foundation, Inc., a 501(c)(3) nonprofit organization with an ambitious and deeply personal mission: To conduct 30 decentralized, pragmatic randomized controlled trials over the next five years, building a rigorous evidence base for additive neuromodulating tools for substance use disorders (SUDs) and brain disorders. These trials will evaluate the effects of specially designed music, guided meditation, and educational inspirational recordings compared to control recordings in SUD and mental health populations. The first trial in opioid use disorder participating in outpatient programs will evaluate listening to test music with specific tonal frequencies, binaural beats, and steady tempo tailored to emotional state, versus control music without these features, adjunctive to usual care, over 24 weeks. In small, highly variable studies, music has been shown to reduce cravings, improve mood, and enhance motivation for recovery. The goal is to modify brainwaves toward a calmer, more regulated state. Inspired by the loss of her son to kratom toxicity in 2021 after nearly twenty months in recovery, Cynthia has committed herself fully to this mission. The foundation operates entirely on donations and grants to fund these trials. Learn more and donate at www.BeatSUD.org
Cynthia serves as co-principal investigator for this groundbreaking program. The specially designed music used in BeatSUD’s trials is not ordinary. The special features of the music being tested activate the dopaminergic reward pathways of the brain, akin to opioids, which is why rigorous research is needed. Results from trials will inform whether these tools should be integrated into clinical practice. The research program is expected to expand into other brain health conditions, including autism, ADHD, PTSD, anxiety, and depression, reflecting her broader commitment to innovative, patient-centered approaches in healthcare.
Throughout her career, Cynthia attributes her success to a deeply goal-oriented mindset and a continuous drive to expand her impact through scientific publications, presentations, symposia, leadership roles, and competitive research funding. She has built a strong international reputation in pharmacoepidemiology and RWE, earning recognition for her contributions to methodological advancement, practical research approaches, and regulatory science. Her professional activities have included organizing and moderating scientific symposia, peer review for journals, webinars and training courses, speaking at international conferences, leading working groups, and delivering lectures at major global meetings and in academia. She has also served on international boards and committees, maintaining a sustained focus on improving research design and elevating scientific standards.
Over time, Cynthia’s definition of success has evolved substantially. While earlier in her career she measured success through academic productivity, professional recognition, pay, and leadership roles, she now defines it in more personal and human terms. Today, she views true accomplishment as the ability to experience peace of mind, show compassion for others, foster meaningful relationships, and contribute positively to the lives of those around her. This evolution in perspective has been profoundly shaped by personal loss, which led her to re-examine the deeper meaning of fulfillment beyond professional achievement alone.
One of the most influential pieces of advice Cynthia received early in her career was to “tell a story”, when presenting scientific findings. She learned that statistical results, epidemiological data, and regulatory reports are most impactful when they are communicated as coherent narratives that clearly explain what the results mean in real-world terms, and how it all ties together. This storytelling approach has become central to her communication style, ensuring that complex scientific findings are relevant, accessible, and actionable for regulators, clinicians, and policymakers.
On a personal level, one of the most transformative influences in Cynthia’s life came from her son during the period they were co-authoring a book together. He encouraged her not to let life pass by passively, but instead to take active ownership of it. He reminded her that many people fall into routines that lead to days blending without intention or fulfillment. His message of not just letting life happen TO you, but rather to make life happen FOR you, continues to shape how she approaches both personal and professional purpose and prioritization.
Cynthia encourages young women entering scientific and healthcare fields to remain authentic, confident, and grounded in their knowledge, even in environments that may still reflect gender imbalance. She emphasizes the importance of speaking up, trusting one’s expertise, and maintaining self-assurance in professional settings. She also advises against equating long working hours with success, encouraging young professionals to intentionally shape their careers while protecting their well-being and family time.
Accordingly, she believes that sustainable success requires thoughtful attention to work-life balance and cautions against accepting environments that demand excessive hours at the expense of personal life, especially children. Reflecting on her own career, she acknowledges that many long workdays and weekends came at the cost of family time, an experience she now views with regret. Her message to younger generations is clear: life should not be defined solely by work, but by meaningful relationships, personal fulfillment, and intentional living. Have you ever noticed how Europeans and Americans respond when asked about themselves? Europeans describe their hobbies, what they enjoy in life, and their children, while Americans describe their job, a striking difference.
In the rapidly evolving field of pharmacoepidemiology and RWE, Cynthia identifies both significant challenges and opportunities. Regulatory agencies such as the FDA and EMA, as well as global payers, are continuously updating requirements, particularly regarding the integration of real-world evidence into regulatory decision-making, and methods continue to evolve and improve. These shifts reflect a broader transformation in how medical evidence is evaluated and applied. The progress is appreciated, but it makes it difficult for overworked individuals to stay current. Her consultants can and do help with this.
Artificial intelligence represents another major force of change. While AI offers potential benefits in efficiency and organization, Cynthia emphasizes that it is not yet fully reliable for scientific or regulatory-grade research due to hallucinations, inappropriate assumptions, inaccurate outputs, and fabricated references. She uses AI selectively for personal organization but remains extremely cautious in applying it to high-stakes client-based research, where accuracy, validation, and confidentiality are essential. She looks forward to improvements in AI accuracy and reliability.
She also notes that organizations are still learning how to appropriately integrate AI into research workflows, leading to both underutilization and overreliance in different contexts. Despite these challenges, she recognizes that the field is evolving rapidly, which requires continuous adaptation and critical oversight.
At the core of Cynthia’s professional and personal philosophy is collaboration. She views herself not as a hierarchical leader at the CEO level but as a collaborator who brings people together around shared goals. Her consulting model reflects this belief, operating as a global network of expert collaborators who contribute their expertise to project-based teams. This approach fosters engagement, trust, and innovation while allowing individuals to contribute their specialized expertise without rigid organizational structures.
Cynthia extends this collaborative philosophy into her philanthropic work as well. BeatSUD Foundation is, at its core, a collaboration of scientists, clinicians, volunteers, donors, SUD researchers, people in recovery, and their family members, all working together toward a shared goal. The foundation operates through volunteer support, donations, and grants, reflecting her belief in shared purpose and collective action.
Ultimately, Cynthia J. Girman’s career reflects a lifelong commitment to scientific excellence, methodological innovation, and human-centered progress. Her work in pharmacoepidemiology and RWE continues to influence how the field generates and applies clinical evidence, and now, through BeatSUD Foundation, she is bringing that same rigor to a problem that is personal, urgent, and vastly underserved. Her aggressive mission of 30 trials in five years, born from personal loss, is driven by the lack of truly credible results, by science, and by compassion for others.
Learn More about Cynthia J. Girman:
Through her Influential Women profile, https://influentialwomen.com/connect/Cynthia-Girman, through her profile on CERobs Consulting, https://www.cerobs.com/team or through the BeatSUD Foundation, https://www.beatsud.org/
Influential Women
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