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… for clinical trials, including: Protocol and statistical analysis plan (SAP) development Sample size calculations … health-state utilities , including mapping to EQ-5D. Q-TWiST Analyses Q-TWiST (quality-adjusted time without …
Regulatory Guidance and Support We can support you throughout your regulatory negotiations. Our team has negotiated with the FDA’s Clinical Outcome Assessments (COA) team and a wide variety of reviewing divisions on numerous occasions to select and …
… Clinical and cost effectiveness of comparator treatments Best practices in economic modeling methods in a disease area … Force on Indirect Comparisons, including: Network meta-analysis and mixed treatment comparisons (MTC) Bayesian and … epidemiological data The outputs from the network meta-analysis are designed to be easily imported into health …
… analyses) or other evaluations for health care interventions. They allow regulators, payers, and other … clinical trials through protocol development, statistical analysis plans, analyses, and reporting - Perform stand-alone … such as NICE, SMC, CDR, and PBAC), value messaging , and publications A Team Approach Let our multidisciplinary team …
… on: Burden (cost) of illness Cost of treatment Health care resource utilization Treatment patterns Medication … 40 different data sources, we’re able to advise you on the best resource—or whether a database study is appropriate at … accessing and extracting data, and developing statistical analysis plans and outcomes measures. As needed, we employ …
… Multi-Criteria Decision Analysis Most drug development and commercialization choices … and select from your alternatives. Multi-Criteria Decision Analysis (MCDA) is an analytical technique that can help you … impact—all within the context of the current standard of care and market conditions. When you understand how various …
… methodological and therapeutic experience who apply best practices and follow a systematic approach that … Patient sampling, recruitment, and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon …
… Analysis of Heterogeneity of Treatment Effects for … genetics, age, gender, physiology, geography, standards of care, or even expectations and preferences—for which your …
… Biostatistics Data Analysis and Visualization Can Help Strengthen Your Pharma or … display of results spanning multiple pages may not be the best medium for clearly communicating your product’s value to … of results Support for scientific presentations and publications And each step will be delivered with the rigor …
… experience developing COAs for use in routine clinical care, such as patient screeners and disease management tools. … modes of administration Qualitative and quantitative analysis Development of documentation, including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …