Stacie Hudgens MSc
Chief Executive Officer,
Strategic Lead Regulatory & Access
Stacie is Chief Executive Officer and Strategic Lead at Clinical Outcomes Solutions with over 20 years of Pharmaceutical industry, academic and consulting experience and has a specialism in Quantitative Science. She is currently the co-chair of the Psychometric Special Interest Group at ISOQOL.
More about Stacie
Stacie has over 20 years of research experience, specializing in research design and statistical and psychometric analysis with extensive US and European Regulatory submissions and presentations including participation on the FDA’s Study Endpoints and Label Development group’s Mixed Methods Panel. She brings 13 years of experience in clinical trials and health and economic outcomes research and 4 years of experience in educational measurement and has developed webinars and symposiums on mixed methods including small sample size psychometric and statistical methodologies.
Stacie’s experience in health economics and outcomes research includes psychometrics, clinical and observational research design, item development and validation, patient-reported outcomes (PROs) in clinical trials, economic modeling, secondary data analysis, and longitudinal and missing data analysis. In addition, she specializes in development of health economic and outcomes studies for regulatory and commercial consideration. She was awarded an early career investigator’s award by ISOQOL for her psychometric methodologies in cross-cultural validation of the FACT-BRM in chronic myeloid leukemia during her tenure as a Senior Statistician with Dr. David Cella at Evanston Northwestern Healthcare.
Stacie has worked and published extensively in multiple disease states, with extensive expertise in oncology and diabetes, and has worked cross-functionally with regulatory, biostatistics, and marketing groups to inform and support PRO measurement strategies in product development. Prior to her position at Adelphi Values, Stacie held dual roles as the PRO, statistical and psychometric expert as well as leading the Internal Studies team of a large pharmaceutical company, in the area of Global Health Economics and Outcomes Research. Previously, Stacie held an Adjunct Faculty position at the Chicago School of Professional Psychology where she taught Research Methods, Introduction and Advanced Statistics.
Stacie developed multiple workshops for surgical residents at Evanston Northwestern Healthcare in clinical research design and statistics. She has also worked extensively with medical board certification agencies teaching item response theory as well as instrument and item design.
Stacie can be reached at our United States Office (Tucson):
1820 E. River Rd, Suite 220 Tucson 85718
Over 20 years of combined clinical and outcomes research experience, specializing in research design and statistical and psychometric analysis with extensive US and European Regulatory submissions and presentations
Formally the Vice President and responsible for the development and global practice of Healthcare Analytics for Adelphi Values as well as Principal Research Scientist of PROs at Takeda Pharmaceuticals
Current adjunct professor at two Universities as well as Co-Chair of the ISOQOL Psychometric Special Interest Group and member of the ISOQOL Industry Advisory Committee
Developed webinars and symposiums on mixed methods including small sample size psychometric and statistical methodologies as well as co-developed a webinar on ClinRO development and validation