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… drug development and post-approval strategies, or answer epidemiologic questions, we can help you design and implement … evidence research using primary data collection—including cohort studies and surveys of patients, physicians, or … adjudication committees Steering committees Obtaining study approval from Institutional Review Boards and Ethics …
… help you develop real-world evidence through a variety of study types—surveys, cross-sectional or longitudinal … you with: Burden/cost of Illness Disease prevalence and incidence Treatment patterns, impact, and adherence Product … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon …
… to advise you on the best resource—or whether a database study is appropriate at all—to use to answer your particular … so you can confidently make good decisions based on your study’s results. Our process includes determining the appropriate analytical methods—including case-control, cohort analyses and pre-post analyses—preparing study …
… experience conducting quantitative evaluations of COAs, evaluating their structure and demonstrating their … evaluations based on clinical trial or observational study data Cross-sectional and longitudinal observational …
… 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 …
… VR, O'Neil C, Weber DJ, Butler AM. Plotting daily incidence of influenza vaccine reactions among patients with end-stage renal disease to inform study design decisions Layton JB , McGrath LJ, Sahrmann JM, … patterns of healthcare utilization, aspects of the study design such as the length of the lookback period or the …
… to regulatory questions Negotiating post-approval study commitments Determining if a post-marketing observational study could address a safety issue of regulatory importance … devices, and combination products Selecting the best study design among alternative approaches Selecting the …
… looking for consulting advice ; database or registry study; prospective observational research ; a literature …
… Antidepressant Drug Utilization Study Antidepressant Use in Denmark, Germany, Spain, and Sweden from 2009 to 2014: Incidence and Comorbidities of Antidepressant Initiators … in Europe since 2012. In the framework of a collaborative study, we conducted a drug utilization study in 5 databases …
Causal Inference for Regulatory-Grade RWE Among the hurdles for making your healthcare interventions available to patients is being able to meet regulatory requirements for estimating the product's safety and/or effectiveness using real-world data (RWD). …