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… system for collecting and reporting serious adverse events (SAEs) for multiphase clinical trials. The web-based … of a report of an SAE to facilitate the reporting of these events in a timely manner. In addition to application …
SIGMA Stakeholder Announcement Share on: January 15, 2021 Launch of the SIGMA Consortium heralds a new era of collaboration to better understand safety and effectiveness of medical interventions. Research institutions compete for resources to carry out …
FORTEO® Post-Market Osteosarcoma Surveillance Program: Real-World Data Contributes to Label Change Share on: January 25, 2021 The US Food and Drug Administration (FDA) is no longer requiring a black box warning on the label for the drug FORTEO® …
RTI Health Solutions Joins MDIC Collaborative Share on: October 18, 2016 RTI Health Solutions Joins Collaborative to Include Patient Risk Preference in Clinical Trials RESEARCH TRIANGLE PARK, NC – (October 18, 2016) – RTI Health Solutions , a business …
FDA and AMCP Guidance on Pre-Approval Submissions and the Continuous Process of Dossier Development Share on: December 20, 2019 Article contributed by: Shahnaz Khan, MPH , Executive Director, Market Access and Outcomes Strategy at RTI Health Solutions …
LaStella Miles Health Economics Headquarters - Research Triangle Park, North Carolina, USA MS, Industrial Engineering BS, Industrial Engineering North Carolina State University, Raleigh, NC LaStella Miles, MS, is an Associate Director of Health Economics …
Lee Bennett Biostatistics Headquarters - Research Triangle Park, North Carolina, USA Graduate Certificate, Mathematics North Carolina State University, Raleigh, NC MS, Statistics University of Georgia, Athens, GA BS, Chemistry Georgia Institute of …
… site management, and reporting spontaneous adverse events with an emphasis on confidentiality and participants’ …
Shardul Odak Surveys and Observational Studies Parsippany, New Jersey, USA MS, Pharmacy Administration University of Georgia, Athens, GA MPharm, Pharmaceutical Science NMIMS University, Mumbai, India BS, Pharmacy RTM Nagpur University, Nagpur, India …
6 Takeaways on the AMCP 4.1 Guidance in Action Share on: March 12, 2021 Insights from Working with Newest AMCP Format Guidance During 2020 In December of 2019, the Academy of Managed Care Pharmacy (AMCP) released Version 4.1 of the AMCP Format for …