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… of results in terms of responder definitions and minimal important difference values to support FDA and EMA … and modern psychometric methods, including those based on item response theory (IRT) and Rasch Measurement Theory …
… and indirect comparisons using standard techniques and have experience with more complex methods recommended by NICE … impact of covariates Methods to assess heterogeneity It is important that the best use of the available data in a …
… would be willing to trade-off (or pay for) to get what is important to them? For example, if your patient has to choose … a bad side effect profile and a less effective drug with minimal side effects, which would they choose? Rooted in traditional economic theory, stated-preference methods have historically been used …
… provide compelling evidence for product registration. We have experience with multiple scales, scoring algorithms, and … Subgroup analysis Identifying patterns of treatment response Analysis of pooled data from multiple studies …
… and after baseline) and proper time zero specification. We have experts who specialize in applying the target trial … randomized trial (i.e. the “target trial”) that would answer your research question. At this stage, we engage with … teaching initiatives—including developing courses in response to proposals by public entities and developing …
… personalized medicine. Drug research focuses on treatment differences and disease differences—much to the exclusion of … Drugs - Rescue, repurpose, or resurrect compounds that may have promising subgroup effects Methods & Applications Using … help you uncover and understand heterogeneity in treatment response among your patients. These efficient methods allow …
… public health, biostatistics, and medicine who have hundreds of combined years of applied experience, we can …
… of standard methodological principles to develop initial item pools Cognitive debriefing interviews to test and refine COA instructions, questions, and response scales Translatability assessment and cross-cultural … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… Registry and Database Analyses Our biostatisticians have experience with multiple real-world data sources … studies using these types of data sources. Our researchers have the necessary expertise to define exposure, covariates, … for the sample design so that the results accurately answer your research questions about the population of …
… literature reviews are appropriate when you need to answer a clearly-formulated question, when reproducibly is important, and to meet formal HTA requirements. Our experts also have the experience to offer guidance and conduct other types …