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… expertise for a wide range of studies, including a large breast cancer registry, a regulated comprehensive … pharmaceutical risk management program, postauthorization safety studies, surveys, meta-analyses, and quality-of-life … protocols, statistical analysis plans, study reports, and publications, as well as project leadership and management. …
Using RTI Rarity™ to Support Clinical Trial Diversity Requirements Local Social Inequity Score Offers Precise Analysis of Social Risk Data The US Food and Drug Administration (FDA) recently released guidance that outlines specific diversity requirements …
… and payer research Preparation of HTA submissions Prospective observational studies Psychometric evaluations of …
… She has extensive experience designing and managing large-scale prospective observational studies, including epidemiologic … has been the design and leadership of post-authorization safety (PASS) studies and risk evaluation and mitigation …
… and strengthen the overall body of evidence regarding safety, effectiveness, and overall value of a product. Per … the evidence, CMS will consider: Source Rigor of the study methodology Current relevance to the selected drug and …
… In this section, question-phrasing is nontechnical and open-ended, to allow anyone to contribute. Requested … paradigm Opportunity for researchers to recommend a methodology, framework, or approach to support CMS in …
Mounting Evidence Suggests Century-Old Hypothesis on How Major Arteries Function is Incorrect Share on: September 17, 2017 Emergence of a new paradigm in understanding the cardiovascular system: pulse synchronized contractions has been published in the …
… and post-approval strategies or place a potential safety signal into the appropriate context. Literature … patterns Utilization and persistence Drug or device safety Effectiveness of treatment or procedure Populations at …
How Much Does TLV Value Rarity? A Review of Reimbursement Maria Kinderås, MSc Senior Associate, Market Access and Outcomes Strategy Transcript Orphan drug reimbursement continues to pose significant challenges for Swedish decision-makers – due often to …
Webinar: Introduction to Network Meta-analysis Share on: Thursday, January 17, 2019, 10 - 11am Watch the recording Healthcare Treatment Decisions Clinicians, patients, and health-policy makers often need to decide which treatment is “best” based on all …