.jpg "Cynthia J. Girman, DrPH, FISPE photo")
Founder & CEO
CERobs Consulting, LLC
Dr. Cynthia Girman, DrPH, FISPE is Founder of CERobs Consulting LLC (www.cerobs.com), which provides services on real world evidence (RWE) study design and methods for descriptive and comparative studies, external control arms and trial endpoint strategies (COAs/PROs). The RWE consulting includes RWE strategy, external controls, protocol and statistical analysis plan development, analysis using RWD and report/manuscript generation. CERobs also conducts systematic and targeted literature reviews and meta-analytic techniques. Work on clinical outcome assessments and patient reported outcomes includes development or adaptation of measures, patient interviews, concept mapping, validation analysis plans for phase 3 trials, FDA briefing books and Evidence Dossiers to justify that COAs/PROs are fit-for-purpose for labeling. Previously at Merck for 33 years, she headed Data Analytics & Observational Methods and created and led two Centers of Excellence: Comparative & Outcomes Evidence in RWE; and Development, Validation, Implementation and Standardization of Endpoints for clinical trials. Cindy is well published, with over 500 manuscripts and abstracts (combined), including a textbook on Pragmatic Randomized Clinical Trials using Primary Data Collection and Electronic Health Records, co-edited with Mary E Ritchey, PhD, FISPE. She is Adjunct Professor of Epidemiology at UNC and in 2014, was the first industry member of PCORI’s Methodology Committee, on which she continues. An active fellow of the International Society for Pharmacoepidemiology, she has served on the Board and co-led the RWE and Regulatory Decisions workgroup before the RWE Task Force became a Special interest Group.