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… Observational Study of Patient-Reported Quality of Life Utilizing a Novel … While there was a broad body of evidence on efficacy and safety there was little information on the day-to-day impact … and robust data collection. APPROACH We conducted a prospective, noninterventional, multicenter longitudinal …
… Rivero-Ferrer E. Transcript As part of a postauthorization safety study sponsored by AstraZeneca, we evaluated cardiovascular safety endpoints related to the use of aclidinium. The study …
… research , health economics , and epidemiology and safety activities. Differentiate with Strategic Statistical … more opportunities to get the most value out of your study, whether exploratory or pre-specified. After analyzing … of results Support for scientific presentations and publications And each step will be delivered with the rigor …
… including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… footprint and the addition of experts in the collection of prospective, retrospective, and ambispective real-world … to meet your research objectives, to developing the study protocol, to obtaining ethics approval, our team is …
… significantly to the knowledge base of the product as study summaries and evidence tables. Include specific types …
… such as NICE, SMC, CDR, and PBAC), value messaging , and publications A Team Approach Let our multidisciplinary team … you need to differentiate your product beyond its safety and efficacy profiles. We combine the measurement …
… to design and analyze data from a wide range of study types, including surveys, cross-sectional or … researchers with assessing the best methods to achieve study objectives and can support interpretation of results …
… administrative databases for comparative effectiveness and safety. Claims databases are a phenomenal resource for … by adjusting for measured confounding. In this study, we used a screening colonoscopy and all-cause …
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 …