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Regulatory RWE Consulting As researchers with advanced degrees in epidemiology, public health, biostatistics, and medicine who have hundreds of combined years of applied experience, we can provide you with reliable, informed, and expert consulting advice …
… Research Let us help you ensure the safety of your patients by examining and understanding disease indicators … and medtech companies reduce the uncertainty of risks to patients who use their products. …
… such as NICE, SMC, CDR, and PBAC), value messaging , and publications A Team Approach Let our multidisciplinary team …
… surveys and observational studies can help you, your patients, regulators, and prescribers understand the … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon …
… item wording and response options) include patients with limited English-language proficiency and health literacy. The FDA may assess an …
… new products to studies of other available options. Standardized guidelines for reporting enable authors, journal … in such analyses. As processes have evolved to include patients and providers, we need to make it so that they can … who might make decisions based on the studies – including patients, providers, and third-party payers. Related …
… use in clinical trials involving both pediatric and adult patients across a wide range of conditions. In addition, we … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… for making your healthcare interventions available to patients is being able to meet regulatory requirements for …
… medicine in any particular controlled group. However, some patients in your study will benefit more or less than the … items/subscales - Power Phase II and recruit appropriate patients Phase II - Refine patient exclusion/inclusion … definitions - Power Phase III and recruit appropriate patients Phase III - Identify subpopulations for market …
… will enable you to demonstrate your products’ value to patients, physicians, caregivers, payers, and policymakers. … Medical Officer of a major private US insurer, and the Pharmacy Director for a large national PBM. Depending on … groups, interviews, surveys, Delphi panels , and mock pharmacy and therapeutics committees—to gain the most useful …