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Looking for a Publication? Search the bibliography for: publications review patient reported outcome orphan drug labels united states january 2006 september
… Patient-Centered Outcomes Assessment Whether your goal is to … We develop and provide support for all types of clinical outcome assessments (COAs), including patient-reported outcome (PRO), observer-reported outcome (ObsRO), …
… HTA and Reimbursement Considerations for Orphan Drugs in European Markets HTA and Reimbursement … diseases. But the available evidence to support orphan drug reimbursement is often of lower quality due to smaller patient populations available for clinical studies. Several …
… other larger projects such as regulatory submissions (e.g. Orphan Drug Applications, Pediatric Investigation Plans, … requirements. In addition, as part of the literature review process, we can perform meta-analyses when suitable … development programs. Incidence of adverse events among a patient population or those taking a certain drug. Review of …
… Analysis of Heterogeneity of Treatment Effects for Patient-Centered Outcomes Let us help you understand your … - Identify and define unique responders - Identify patient-reported outcome items/subscales - Power Phase II and recruit …
… preparing the search protocol to conducting the search and review and extracting results, our quality-controlled … deliverables. When the information from a literature review is combined with meta-analyses to synthesize the …
… How Do We Get Drug Labeling Based on Patient Reported Outcomes? With Ari …
… Webinar: Strategic Planning for Orphan Drugs Share on: Tuesday, June 7, 2022, 10 - 11am … product value to support successful reimbursement and patient access. Creating a strategic plan with a Market … You’ll learn about strategic planning necessary for orphan drug development as we cover: Market Access Evidence Roadmaps …
… RTI-HS Webinar - Lessons Learned From a Review of FDA PRO Labeling Share on: December 12, 2016 Image … Labeling The last decade has seen an increased focus on patient-centered drug development. Product labeling based on patient-reported outcomes (PRO) endpoints are therefore of special …
Navigating EU Joint Clinical Assessments and Joint Scientific Consultations From January 2025 Onward
… drugs and cell and gene therapies from January 2025, orphan medicinal products from January 2028, and lastly, all … studies. This includes fundamental criteria, such as patient populations, comparator selection, relevant … the European Union and the Inflation Reduction Act in the United States …
… . We can help you: Services Strategy and Consulting - Review and determine whether existing utility estimates are … 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 , …