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PIE and Post-Approval AMCP Dossiers Image Pre-Approval Information Exchange (PIE) Materials Unapproved Medical Product Dossiers and Unapproved Use Dossiers An unapproved product dossier, or an unapproved use dossier, allows you to communicate key product …
Multi-Criteria Decision Analysis Most drug development and commercialization choices are complex. When you have multiple factors influencing a decision and you have to consider tradeoffs, you need a tool that can help you compare, prioritize and select …
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 …
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 …
Benefit-Risk Assessment Do your product’s benefits outweigh its potential risks? More importantly, do you have the right data to credibly demonstrate this to regulators, payers, physicians, and patients? You can rely on our experienced team to help you …
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 …
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. …
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 …
Literature Reviews and Meta-analyses We conduct literature reviews and meta-analyses using the most rigorous methodologies, so you get reliable and reproducible answers to your research questions. High-quality literature reviews can help you understand: …
Clinical Trials With broad therapeutic experience across all phases of clinical development, we can provide a complete set of statistical services for clinical trials, including: Protocol and statistical analysis plan (SAP) development Sample size …