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Economic Qualitative Inquiry, Policy, and Access Our focused research will enable you to demonstrate your products’ value to patients, physicians, caregivers, payers, and policymakers. With so many public, private, and non-traditional payers and their …
… represents the first population-based observational study in the United States assessing the success of CDK4/6 … patients with HR+/HER2– metastatic breast cancer. Links to publications: Goyal RK, Chen H, Abughosh SM, Holmes HM, … in the United States. Breast Cancer Res Treat. Feb;198(1):159-166 (2023). https://doi.org/10.1007/s10549-022-06845-4 …
… Using Primary Data Collection To meet the requirements of risk management programs, inform drug development and … adjudication committees Steering committees Obtaining study approval from Institutional Review Boards and Ethics Committees Managing study operations: Site recruitment Monitoring Incentive …
… 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 … with a wide range of data partners, including: Behavioral Risk Factor Surveillance System (BRFSS) CPRD Drug Abuse …
… information that can help you understand and communicate risk tolerance from patients and other stakeholders to inform … can also help catalog issues that could arise in benefit-risk assessments . Additionally, the decision process can be …
… to regulatory questions Negotiating post-approval study commitments Determining if a post-marketing observational study could address a safety issue of regulatory importance within a risk management plan Designing studies to evaluate the …
… stroke patients for intravenous recombinant tissue plasminogen activator (IV tPA) treatment would be offset by improved …
… economic, PRO /QoL value A Roadmap: Tactical project and study recommendations for filling the gaps Market Access …
… Publication Management and Medical Writing Publications are critical for the dissemination of your … and internal milestones is an integral part of the publications process. We develop a customized timeline for … following best practices. Our publication managers submit publications to journals across the spectrum of scientific …
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). …