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… including regulatory submissions, reports, and publications Support to secure regulatory acceptability of COAs Evaluation of feasibility and acceptance for routine clinical care …
… development Advisory board set up and facilitation Feasibility assessments Regulatory and ethics submissions … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon … tablet applications Electronic data capture (EDC) via the web Smartphone data collection and transmission Handheld …
… Patient-Centered Outcomes Assessment Whether your goal is to … clinician-reported outcome (ClinRO), and performance-based outcome (PerfO) measures. To provide you with … economics , market access , health-preference assessment , survey research , and biostatistics . More About Our Expert …
… 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 , … testing, instrument development , conjoint analysis , survey research , biostatistics , market access value …
… Psychometric Evaluation Our psychometricians have extensive experience … classical and modern psychometric methods, including those based on item response theory (IRT) and Rasch Measurement … studies to collect data to support psychometric evaluation (independent from clinical trials) Equivalence …
… experiences and treatment preferences. Creation of a Web-Based Survey Researchers created a web-based survey that was sent …
… development and market access objectives. QoL Analyses Patient-centered outcomes and other quality of life (QoL) … treatment toxicity to make informed treatment decisions based on the relative importance they place on different … study, we can apply the Q-TWiST method to quantitatively assess the benefit/risk tradeoff of your new treatment …
… with A-CASI, EDC systems, IVRS, phone interviews, web-based, paper/fax forms, interviews, chart abstractions, etc.) …
… the expertise essential for developing a robust plan to assess benefits and risks. Once we have helped you develop a … generation and communication strategy Incorporating patient and/or provider preferences and patient perspectives Selecting the best metrics for measuring …
… New Patient-Reported Outcomes Diary for Rare Acromegaly Disorder … the use of PROs in clinical trials to accurately assess treatment benefits. These measures should be carefully … measures were available for acromegaly that were developed based on FDA guidance. Experienced qualitative interviewers …