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… effects is an important part of evaluating the benefit-risk balance of their products. However, primary efficacy … duration Evaluated the design and methodology of each study to ensure that they met quality standards and that the … treatment effect for standard of care using historical control data from NIH-sponsored studies Matched subjects …
… i Rózpide, 7-9, Les Corts 08034 Barcelona Barcelona Spain Learn to Use Target Trial Emulation for Regulatory … Static and dynamic exposure strategies: implications for study design and analysis Target trial emulation and …
… support more inclusive and equitable health outcomes. Our case study identifies three ways to apply principles of EDIB to … drug and medtech development. First, at the study design phase, promote diversity among study teams to …
… and treatment effectiveness Critical satisfaction measures Risk management strategies Risk tolerance assessments Let our Health Preference …
… reporting requirements across the trials for both clinical study reports and HTA submissions. OUR APPROACH Our approach … scores and other covariates Analyses to compare the risk of deterioration in HRQOL between treatment groups and …
Medical Technologies Chart a complete course to commercial success. Identifying an unmet need in the market and meeting regulatory requirements is only half of the commercialization picture. All too often we see manufacturers focus on the regulatory …
… Josep Marsal Biostatistics Barcelona, Spain PhD, Public Health and Biomedical Research Methodology Universitat Autònoma de Catalunya, Barcelona, Spain MSc, Statistics BSc, Statistics Universitat Politècnica … on primary care studies. Dr. Marsal has coauthored over 80 publications in medical literature and was a reviewer of …
… intelligence (AI) and advanced spatial analytics in a risk-adjustment framework. Called RTI Rarity™, this database … predictive analytic methods to provide localized SDOH risk scores constructed with a health equity focus. It … from the American Community Survey, Centers for Disease Control and Prevention, Opportunity Atlas, and Department of …
… such as NICE, SMC, CDR, and PBAC), value messaging , and publications A Team Approach Let our multidisciplinary team …
… Katica Boric Pharmacoepidemiology and Risk Management Barcelona, Spain PhD, Science, Neuroscience MSc, Science in Biological … is Research Epidemiologist in the Pharmacoepidemiology and Risk Management group with RTI-HS. Dr. Boric has extensive …