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… development, we can provide a complete set of statistical services for clinical trials, including: Protocol and … In addition, our statisticians are well versed in outcomes research methods and will work with you to plan and … we provide a wide variety of exploratory data analysis services to extend the utility of your trial data. Our …
… New FDA Draft Guidance For Evaluating Patient-Reported Outcomes in Clinical Trials Share on: September 3, 2020 On … Related Services Patient-Centered Outcomes Assessment Staff Members Ari Gnanasakthy Lori McLeod …
Measurement Strategies With a deep understanding of the regulatory environment and reimbursement issues pertaining to clinical outcome assessments (COAs), we work with you to develop and support optimal measurement strategies for your products in …
… How Do We Get Drug Labeling Based on Patient Reported Outcomes? With Ari Gnanasakthy , MBA, MSc, Principal Scientist, Patient-Centered Outcomes Assessment at RTI Health Solutions. Transcript A …
Market Access and Evidence Generation Strategies At every stage of your product’s lifecycle, we can help you develop a strategic roadmap to effectively demonstrate and communicate your product’s value . For clinical and commercial teams alike, we provide …
… PRO instruments and other types of COAs to assess health outcomes, such as symptom severity, health-related quality of … and disease management tools. Our instrument-development services apply to all modes of administration (e.g., paper, …
Regulatory Guidance and Support We can support you throughout your regulatory negotiations. Our team has negotiated with the FDA’s Clinical Outcome Assessments (COA) team and a wide variety of reviewing divisions on numerous occasions to select and …
… across our health economics and market access and outcomes strategy teams have experience contributing to …
… our expert pool of survey experts, health economists , outcomes researchers , epidemiologists , biostatisticians , … Pragmatic clinical trials Time and motion Patient-reported outcomes and health-related quality of life Patient … for contacting subjects via telephone As part of our services, we liaise with RTI’s central IRB , develop data …
… decision making in routine clinical care. Our psychometric services include: Psychometric analyses using both classical … biostatistics team to support analyses for clinical trial outcomes. …