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… Mordin Market Access and Outcomes Strategy Psychiatry Pain Medical Technologies Dermatology CNS/Neurology Telecommuter - … studies. Her areas of expertise include study design (e.g., observational postmarketing studies, … life and satisfaction surveys), analysis of outcomes data, publication development, and outcomes-related regulatory …
… In his role at RTI-HS, he provides research and medical writing support for evidence-based dossiers, systematic and …
… economics, and drug safety. His responsibilities include writing statistical analysis plans and study reports and … types of data sources such as observational studies, medical record databases (e.g., Clinical Practice Research …
… to Payers in the US In the US, once a drug or medical device has been approved or received clearance, … safety, and cost-effectiveness to support formulary management, coverage, and reimbursement decisions. … on incidence and prevalence Product-related programs or services (e.g., patient support programs) Presentations of …
Global Value Dossiers and Other Value Communication Materials Your messages need to be flexible, tailored to each of your audiences, and clearly articulated. Let us help develop your global value dossiers (GVDs) and other high-impact communication tools …
… products, including drugs, vaccines, biologics, and medical devices. Having a collective network of data …
… Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.” While its title suggests that the draft guidance applies only to medical devices, the best practices outlined by the agency … PROs intended to support drug submissions as well as medical devices. The draft offers several recommendations …
… Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.” While its title suggests that the draft guidance applies only to medical devices, the best practices outlined by the agency … Related Services Patient-Centered Outcomes Assessment Staff Members …
… therapies (also known as cell and gene therapies), and medical technologies. Therapies for rare diseases will be … the development of therapies that address high unmet medical needs as well as the use of comparative clinical … needs, and patient preferences. We support clinical trial design by incorporating multistakeholder viewpoints, with a …
… on incidence and prevalence) Product-related programs or services Factual presentations of results from studies, … from studies, a description of material aspects of study design and methodology, and disclosure of material … should be presented to payors by staff with appropriate medical and scientific credentials and applicable …