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… our presentation. If you would like to speak with us about how we can help you with your specific Global Value Dossier … A GVD is an internal document that does aim to present a product in good light. Nonetheless, it also needs to be … prefer a GVD—which provides guidance to affiliates on the attributes of a product and how best to demonstrate these by …
… information from manufacturers. They can ask for data on product effectiveness, safety, and cost-effectiveness to … FDA approval of the product or of the new use Product pricing information Patient utilization projections such as … channel that hasn’t existed before. For help understanding how to develop effective and appropriate dossiers for …
… Benefit-Risk Assessment Do your product’s benefits outweigh its potential risks? More … this to regulators, payers, physicians, and patients? You can rely on our experienced team to help you navigate the … post-approval activities. This includes: Understanding how a structured approach can improve your evidence …
… Inform Your Early Product Development Decisions …
… you better understand drivers that could influence your product strategy. Chart reviews, separately or in combination with other data sources or surveys , can help you understand: Clinical disease characteristics … of illness Country-specific economic endpoints, which can be used to populate decision-analytic models (i.e., cost …
… our international and expert team of epidemiologists can help you ask the right questions and apply the right … ; a literature review ; or a risk management plan, we can provide you with high-quality, scientifically-rigorous, … Head of Epidemiology at RTI Health Solutions, talks about how we help pharma, biotech, and medtech companies reduce the …
… your research questions. High-quality literature reviews can help you understand: Definitions, etiology, and diagnosis … in economic modeling methods in a disease area Economic model inputs including resource use, cost, and utility … synthesize the evidence quantitatively, new information can be generated that was not available from the individual …
… rates used for cost and outcomes, and willingness-to-pay thresholds. Economic assessment is linked to national …
… economic evaluations are going to play a key role in pricing, access, and reimbursement decisions. … Collaboration on Alzheimer’s Disease organized a model cross-comparison challenge. Eight independent modeling … groups’ modeling approaches to understand differences in how they used the clinical trial data in their respective …
… and implemented surveys and observational studies can help you, your patients, regulators, and prescribers … and incidence Treatment patterns, impact, and adherence Product safety and risk minimization evaluations (e.g., PASS, … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon …