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… experience includes preparation of protocols, clinical study reports, and manuscripts in the areas of rare diseases, … regular basis in order to remain up-to-date on the latest news regarding AMCP dossiers. …
… experienced in developing decision analytic models such as cost-effectiveness, cost-utility, and budget-impact models to evaluate the health …
Integrated Evidence Generation Strategy Long-Range Planning for Improved Alignment and Efficiency Biopharma companies have long relied on planning exercises to help inform their product development process. But traditional approaches have their …
… health economics and outcomes research studies, including cost-effectiveness, cost-benefit, cost-minimization, and budget-impact modeling. …
… deep vein thrombosis, venous thromboembolism, acute coronary syndrome, hypertension, stroke, atherosclerosis, …
… studies. This helps in implementing appropriate study design for both regulatory and HTA purposes. However, …
… VAC4EU , the Vaccine Monitoring Collaboration for Europe study network, we are helping to increase the availability of …
… (including feasibility assessments, all versions of the study protocol, statistical analysis plan, etc.), the … the importance of early engagement with the FDA at the study design stage. Some additional key recommendations are as follows: Sponsors should post study protocols publicly to ensure transparent data …
… with Tusker Medical to design and implement a preference study to understand parents’ willingness to choose the Tula procedure. The study explained the in-office and OR-based procedure options … trial was set using the results from the Preference Study, an important advance in regulatory science. “For …
… Director of Health Economics at RTI-HS. Dr. Dong develops cost-effectiveness models to evaluate the health and economic … health technologies. She is experienced in developing cost-effectiveness models and analyses in the areas of …