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… safety studies, using data sources from the United States (US) and Europe, as well as conducting feasibility assessments … research teams in protocol development, human subjects’ regulatory compliance, questionnaire development, participant … report development, and manuscript preparation for both US-based and international projects. …
… how that evidence will be prioritized. The goal of the US Inflation Reduction Act (IRA) program is to negotiate a … Market data and revenue and sales volume data in the US There is, however, no specific information on how CMS … federal healthcare program determinations, passed in the US House in February 2024. New laws around the use of QALY …
… target trial emulation. We also have methods that allow us to emulate conditional randomization by adjusting for …
… coordinating epidemiologic studies and projects including regulatory driven literature reviews with multiple … with reporting study progress both to clients and to regulatory agencies and contributes to dissemination …
… optimal vaccination coverage for older adults in the US Health guidelines recommend that older adults in the US be vaccinated for vaccine-preventable influenza, whooping … Researchers also accounted for the projected shift in the US population toward older age groups over the study period. …
… She has prepared documentation pertaining to COAs for regulatory submissions to support PRO labeling claims. She … and growth mixture modeling. Dr. Nelson has several publications and presentations in the fields of psychology … including manuscripts in Therapeutic Innovation and Regulatory Science, Value and Health, Quality of Life …
… experience includes overseeing compliance with appicable regulatory regulations and ethics submissions management. She …
… with a focus on oncology and gastroenterology. She has key regulatory experience, having participated in numerous FDA … outcomes particularly in oncology studies, with numerous publications in this area. Her experience spans both the …
… and expertise lie, you'll have opportunities to grow with us. …
… His collaboration with health economic modellers, regulatory consultants, patent attorneys, clinicians, and … clinical researchers, generated many peer-reviewed publications, contributed to medical device regulatory applications to the Food and Drug Administration …