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… Medical Communications and Strategy As HEOR and RWE continue to grow in importance, it is critical to … and Strategy Team Offers: Extensive experience developing publications in pharmacoepidemiology, patient-centered … tactical plans efficiently and effectively. The Complete Publications Experience RTI-HS partners with you to develop …
… Collaborative Regulatory RWE Research Through our Barcelona based team, we are a … the registration of pharmacoepidemiological and regulatory RWE studies. Susana Perez-Gutthann has been elected Co-Chair … evidence for regulatory purposes, improve interoperability between studies and data sources, and improve transparency. …
… Regulatory Guidance and Support We can support you throughout your … negotiated with the FDA’s Clinical Outcome Assessments (COA) team and a wide variety of reviewing divisions on … liaising with the EMA to negotiate acceptability of COA-based endpoints for use in label claims, as well as …
… 2020 FDA Patient-Reported Outcomes Guidance Draft On August 31, 2020, the FDA released its draft … by considering the similarities and differences between the population in the pivotal clinical study (e.g., …
… Causal Inference for Regulatory-Grade RWE Among the hurdles for making your healthcare …
… Global Value Dossiers and Other Value Communication Materials Your messages need to be flexible, … can conduct interactive workshops to maximize engagement between attendees and ensure active learning. Your Value … product’s value story, you need to take into account many different factors and perspectives. Below are some of the key …
… Regulatory RWE Consulting As researchers with advanced degrees in …
… facilitate market access, or improve patient-clinician communication, our Patient-Centered Outcomes Assessment … and support measurement strategies Provide regulatory guidance and support Conduct clinical trial exit interviews …
… RWE Studies Using Primary Data Collection To meet the …
… pools Cognitive debriefing interviews to test and refine COA instructions, questions, and response scales … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …