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… Instrument Development In accordance with regulatory guidelines and … health outcomes, such as symptom severity, health-related quality of life, functional status, and patient satisfaction … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… of illness studies Global Value Dossiers Health-related quality-of-life analyses Literature reviews Measurement of patient … options Meta-analysis studies Outcomes research strategy development Psychometric evaluations of PRO instruments …
… PIE and Post-Approval AMCP Dossiers Image Pre-Approval Information … Unapproved Medical Product Dossiers and Unapproved Use Dossiers An unapproved product dossier, or an unapproved … clinical data with stakeholders. We can also support your development of PIE webinars which allow your chosen clinical …
… used in health economic models (for example, to calculate quality-adjusted life years [QALYs] in cost-effectiveness … the utility data needed to achieve your product development and market access objectives. Our integrated team … such as NICE, SMC, CDR, and PBAC), value messaging , and publications A Team Approach Let our multidisciplinary team …
… A Global Review of Quality-of-Life Impact A Global Review of Quality-of-Life Impact of Atopic Dermatitis in Children …
… Observational Study of Patient-Reported Quality of Life Utilizing a Novel Mobile Application OPPORTUNITY Our … patient journey and assess patient-reported outcomes of women using their treatment for advanced or metastatic breast …
… we understand your need for credible, reliable, and high-quality evidence-based analyses. Leverage the wide-ranging … costs; cost of treatment and health-related quality of life; healthcare resource utilization Treatment Patterns … and budget impact models, HTA submissions , and post-submission support …
… To provide you with comprehensive support from clinical development to post-marketing, the PCOA team routinely collaborates with … conducted thousands of successful projects involving the development, implementation, and regulatory support of …
… the requirements of risk management programs, inform drug development and post-approval strategies, or answer epidemiologic questions, …
… Multi-Criteria Decision Analysis Most drug development and commercialization choices are complex. When … across its lifecycle—including efficacy, safety, impact on quality of life and functional status, dosing convenience, price, …