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… Patient-Centered Outcomes Assessment Whether your goal is to … We develop and provide support for all types of clinical outcome assessments (COAs), including patient-reported outcome (PRO), observer-reported outcome (ObsRO), …
… Measurement Strategies With a deep understanding of the … and reimbursement issues pertaining to clinical outcome assessments (COAs), we work with you to develop and support optimal measurement strategies for your products in development, …
… Analysis of Heterogeneity of Treatment Effects for Patient-Centered Outcomes Let us help you understand your … - Identify and define unique responders - Identify patient-reported outcome items/subscales - Power Phase II and recruit …
… of strength of preference for a given health-related outcome such as a health state event or treatment … such as NICE, SMC, CDR, and PBAC), value messaging , and publications A Team Approach Let our multidisciplinary team … knowledge of our experts in health economic modelling , patient-centered outcomes assessment , psychometrics , …
… existing measures to support your product approval and labeling claims. We also identify and develop COAs to support … health-related quality of life, functional status, and patient satisfaction for use in clinical trials involving … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… product’s treatment features, do you know how much your patient’s value it? Willingness-to-pay (WTP) can be estimated … benefit and can answer questions like what’s it worth to a patient if: The dosing regimen changes from 3 times a day to … to pill? Efficacy increases or side effects decrease? Our Approach Our scientifically-rigorous approach to WTP ensures …
… and will work with you to plan and analyze your clinical outcome assessments to help achieve your product development and market access objectives. QoL Analyses Patient-centered outcomes and other quality of life (QoL) … they place on different health outcomes. Even if patient-reported QoL data was not collected in your study, we can …
… With an increased regulatory focus on incorporating patient perspectives in drug development, patient-reported outcomes, known as PROs, are playing an increasingly … between a PRO and a more familiar clinician-reported outcome or biological marker. Most of the research in this …
… 2020 FDA Patient-Reported Outcomes Guidance Draft On August 31, 2020, the FDA … Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.” …
… Our team has negotiated with the FDA’s Clinical Outcome Assessments (COA) team and a wide variety of … clients to FDA meetings in support of their proposed labeling claims. Our experts, particularly those based in Europe, also …