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… Multi-Criteria Decision Analysis Most drug development and commercialization … are complex. When you have multiple factors influencing a decision and you have to consider tradeoffs, you need a tool … and select from your alternatives. Multi-Criteria Decision Analysis (MCDA) is an analytical technique that can …
… and scientific information about your products ahead of FDA approval can help improve patient access to emerging therapies and devices. Work with … key disease and unmet need evidence to US health care decision makers. Getting this valuable information into the …
… Benefit-Risk Preferences Benefit-risk preference studies are a specific … and are used to determine how your patients and other decision-makers perceive the benefits of your treatment … the relative importance of benefits and risks and a patient’s maximum acceptable risk (MAR). If the actual risk …
… to get what is important to them? For example, if your patient has to choose between a highly effective drug with a … Our experts have been applying these methods to medical decision making for nearly two decades. What we and our … you understand your patients’ (or other stakeholders’) preferences and predict how they value different treatment …
… Recent FDA Drug and Device Guidelines for Sharing Pre-Approval … before an approval decision and accelerate their time to market launch. Pre-approval communication with … study protocols about endpoints being studied and the patient population under investigation Anticipated timeline …
… New System for Ear Tube Insertion Approved by FDA: General Anesthesia Not Required Share on: January 7, … (OR). In November, the U.S. Food and Drug Administration (FDA) granted approval to Tusker Medical’s Tula System. The … this that support the FDA regulatory process and advance patient care.” Related Services Health Preference Assessment …
… the drug development process. The Alzheimer’s Disease Patient and Caregiver Engagement (AD PACE) initiative is a first-of-its-kind collaboration among pharmaceutical … and then quantifying the treatment-related needs, preferences, and priorities of those living with and affected …
… FDA and AMCP Guidance on Pre-Approval Submissions and the … Access and Outcomes Strategy at RTI Health Solutions FDA Guidance In June 2018, the United States Food and Drug … of the product or new use Product pricing information Patient utilization projections (e.g., epidemiological data …
… Decision-Analytic Models Decision-analytic models provide a framework for compiling … and other stochastic process models Simulation (individual patient, discrete-event, etc.) Communicable disease models … provide you with the highest-quality deliverables on time and within budget. …
… - Perform health state valuation studies using time-tradeoff and standard gamble - Capture utility data real-time, as events occur, via mobile technology solutions (e.g., … knowledge of our experts in health economic modelling , patient-centered outcomes assessment , psychometrics , …