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… Administration (FDA) has now released final guidance about using real-world evidence (RWE) to support regulatory … a reference for researchers and sponsors designing studies using RWE that are intended to be submitted to the FDA. In … on data accuracy, adherence to the study plan, and prompt evaluation and remediation of deviations. RTI Health …
… research has resulted in numerous abstracts and almost 40 publications. Throughout his career, Mr. Gnanasakthy has … instruments and currently serves in the editorial board of Cancer Clinical Trials and a reviewer for many professional …
… therapeutic areas and also has experience in meta-analytic techniques. Prior to working at RTI-HS, Dr. Hartley worked at … Epidemiology. In her PhD, Dr. Hartley used meta-analytic techniques to investigate the existence of intercontinental … Heart Group and has a certificate in Advanced Search Techniques for Systematic Reviews, HTA, and Guidelines from …
… population. Dr. Korgaonkar has experience conducting observational outcomes research across different therapeutic … disorders, diabetes, inflammatory bowel disease, and cancer. She has worked with diverse data sources including … in conceptualization of observational studies and analysis using SAS, SPSS, and Stata. …
… ESMO Annual Congress. Radiographic progression‑free survival correlation with time‑to‑event endpoints: a post hoc …
… results (e.g., scientific conferences, peer-reviewed publications ) …
… experience in designing and conducting retrospective observational studies based on large population level … and access, in a variety of disease areas, including cancer, mental health, pain, cardiovascular disease, … patterns, health care utilization and burden of illness using retrospective claims and administrative databases …
… trials, pragmatic clinical trials, network meta-analyses, observational studies, and real-world evidence. Both ICRs … for detailed responses. Dossiers should be formatted using an industry standard such as the AMCP Format for … The intent of Q46 is to collect clinicians’ experience in using the selected drug and understand how they assess …
… and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Our …
… outcomes research, patient preference, and economic evaluation, to reimbursement and safety activities. We start …