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… Multi-Criteria Decision Analysis Most drug development and commercialization … factors influencing a decision and you have to consider tradeoffs, you need a tool that can help you compare, prioritize and select from …
… Decision-Analytic Models Decision-analytic models provide a … analysis Our Approach From design to deliverables, publications , and ongoing support, we develop and validate models according to ISPOR, …
… and final data analyses Clinical Study Reports (CSR) Support for regulatory agency submissions In addition, our … an approach that can help patients evaluate the trade-off between clinical benefit and treatment toxicity to make … Analysis of pooled data from multiple studies Associations between clinical and patient-centered outcomes Assessing …
… Study Design and Implementation From consulting support to managing multi-national, multi-year, late-phase … help inform your regulatory, clinical, and market access decision-making. All projects are led by senior staff with … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon …
… Regulatory Guidance and Support We can support you throughout your regulatory negotiations. Our team … of reviewing divisions on numerous occasions to select and support measurement strategies acceptable to the FDA …
… such as NICE, SMC, CDR, and PBAC), value messaging , and publications A Team Approach Let our multidisciplinary team … you need to differentiate your product beyond its safety and efficacy profiles. We combine the measurement …
… help you develop new COAs and modify existing measures to support your product approval and labeling claims. We also identify and develop COAs to support reimbursement decisions and publication strategies. … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… data may contain a goldmine of information to support your asset. You can develop insights into the patient … research , health economics , and epidemiology and safety activities. Differentiate with Strategic Statistical … of results Support for scientific presentations and publications And each step will be delivered with the rigor …
… to them? For example, if your patient has to choose between a highly effective drug with a bad side effect … Our experts have been applying these methods to medical decision making for nearly two decades. What we and our … methods—to your research question so you can make better product and market decisions. Health Preference …
… We conducted a systematic review of evidence reports to better understand how evidence ratings are assigned and … improvement in clinical outcomes without longer-term safety evidence OR less impressive efficacy with longer-term … We found only 4 instances where evidence ratings changed between draft and final reports, supporting our previous …