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… health-related quality of life, functional status, and patient satisfaction for use in clinical trials involving … Migration to alternative modes of administration Qualitative and quantitative analysis Development of … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… Economic Qualitative Inquiry, Policy, and Access Our focused research … private insurers, CMS, CADTH, NICE, IQWiG, HAS) about your new product, we can help you understand the clinical and … need to clearly communicate to payers, prescribers, and patient advocates the unique value provided by your products. …
… New Patient-Reported Outcomes Diary for Rare Acromegaly Disorder … Diary (ASD) to help patients with acromegaly capture their experiences with symptoms and treatment outcomes associated … that were developed based on FDA guidance. Experienced qualitative interviewers spoke to patients from the …
… Patient-Centered Outcomes Assessment Whether your goal is to … product claims, facilitate market access, or improve patient-clinician communication, our Patient-Centered … To provide you with comprehensive support from clinical development to post-marketing, the PCOA team routinely …
… to DCEs ensures actionable results to inform your drug development and market access strategies. For your project, … for each study that are representative of the target patient population(s). Our experience includes numerous … recruitment techniques including working with sites, patient advocacy groups, patient panels, and social media. …
… New FDA Draft Guidance For Evaluating Patient-Reported Outcomes in Clinical Trials Share on: … (for example, itching may be more important than dry skin). Content validity evidence may be generated by … of evidence derived from literature review, KOL input, and qualitative research with patients, caregivers, and other …
… 2020 FDA Patient-Reported Outcomes Guidance Draft On August 31, 2020, … (for example, itching may be more important than dry skin). Content validity evidence may be generated by … of evidence derived from literature review, KOL input, and qualitative research with patients, caregivers, and other …
… 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 … knowledge of our experts in health economic modelling , patient-centered outcomes assessment , psychometrics , …
… therapeutic experience across all phases of clinical development, we can provide a complete set of statistical … development and market access objectives. QoL Analyses Patient-centered outcomes and other quality of life (QoL) … to quantitatively assess the benefit/risk tradeoff of your new treatment regimen. Healthcare Resource Utilization Our …
… Analysis of Heterogeneity of Treatment Effects for Patient-Centered Outcomes Let us help you understand your … disease differences—much to the exclusion of individual patient differences. In fact, by design, randomized clinical … they be identified efficiently? To support your clinical development AND your commercialization strategy, we can help …