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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 …
Benefit-Risk Preferences Benefit-risk preference studies are a specific application of stated-preference methods and are used to determine how your patients and other decision-makers perceive the benefits of your treatment features and their tolerance for …
Psychometric Evaluation Our psychometricians have extensive experience conducting quantitative evaluations of COAs, evaluating their structure and demonstrating their reliability, validity, and responsiveness, as well as facilitating the interpretation of …
… and that we can help answer. Key Factors Key Questions About Your Product Patient Perspective Can I afford it? Is it …
Instrument Development In accordance with regulatory guidelines and expectations in the US and Europe, we can help you develop new COAs and modify existing measures to support your product approval and labeling claims. We also identify and develop COAs to …
Market Access and Evidence Generation Strategies At every stage of your product’s lifecycle, we can help you develop a strategic roadmap to effectively demonstrate and communicate your product’s value . For clinical and commercial teams alike, we provide …
Willingness-to-Pay Given your product’s treatment features, do you know how much your patient’s value it? Willingness-to-pay (WTP) can be estimated using a number of stated-preference methods including discrete-choice experiments and contingent valuation. …
Retrospective Chart Reviews Like database studies , retrospective chart reviews also use real world data to help you better understand drivers that could influence your product strategy. Chart reviews, separately or in combination with other data sources …
RWE Studies Using Primary Data Collection To meet the requirements of risk management programs, inform drug development and post-approval strategies, or answer epidemiologic questions, we can help you design and implement real-world evidence research …
… assessment , survey research , and biostatistics . More About Our Expert Team Our team includes more than 30 …