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… Instrument Development In accordance with regulatory guidelines and … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of COAs Evaluation of feasibility and acceptance for routine clinical …
… Psychometric Evaluation Our psychometricians have extensive experience … studies to collect data to support psychometric evaluation (independent from clinical trials) Equivalence … testing across modes and languages of administration Development of short forms and measures based on …
… Utility Assessment Health utility estimates provide a representation … the utility data needed to achieve your product development and market access objectives. Our integrated team … such as NICE, SMC, CDR, and PBAC), value messaging , and publications A Team Approach Let our multidisciplinary team …
… therapeutic experience across all phases of clinical development, we can provide a complete set of statistical … Q-TWiST Analyses Q-TWiST (quality-adjusted time without symptoms or toxicity) is an approach that can help patients evaluate the trade-off between clinical benefit and treatment …
… Patient-Centered Outcomes Assessment Whether your goal is to support product claims, … To provide you with comprehensive support from clinical development to post-marketing, the PCOA team routinely … conducted thousands of successful projects involving the development, implementation, and regulatory support of …
… Preference studies can be used to help you with: Product development strategies Product positioning and value messages … Risk tolerance assessments Let our Health Preference Assessment team help you understand your patients’ (or other … better product and market decisions. Health Preference Assessment at RTI Health Solutions Christine Poulos, Senior …
… Benefit-Risk Assessment Do your product’s benefits outweigh its potential … for possible new studies to include in your clinical development program and clarify appropriate post-approval … additional risk minimization measures, and studies to evaluate their effectiveness Initiating postmarketing safety …
… Outcome Instruments for Use in Medical Device Evaluation.” While its title suggests that the draft … The draft offers several recommendations related to the development, evaluation, and regulatory review of clinical … frequency, severity, interference with activities of daily living). The agency recognizes that patients may …
… Romano, M.S., Vice President of Patient-Centered Outcomes Assessment at RTI Health Solutions, will be presenting at the … (DeMuro) Romano has extensive experience in the rigorous development and psychometric evaluation of clinical outcome assessment measures for use in …
… do not supply adequate relief for their most troublesome symptoms. To help improve lives, new treatments need to … for mode and frequency of administration (oral tablet once daily, oral tablet twice daily, biweekly injections, or … Kelley Myers , Research Economist in the Health Preference Assessment group at RTI Health Solutions shares, …