The State of Open Source Technology in Clinical Data Analysis, Reporting, and Submissions скачать в хорошем качестве

The State of Open Source Technology in Clinical Data Analysis, Reporting, and Submissions

Abstract This talk provides awareness on an initiative to be delivered through the PHUSE Board of Directors, Open Source Technologies Director. We will share the why, how, and vision for a “state of the union”-style manuscript that aims to comprehensively describe where the pharmaceutical industry is at with respect to embedding open source solutions into its processes for clinical data analysis, reporting, and submissions. What do we know? What have we asked, but still do not know? What have we not even asked yet? What work still has to be done to get to business-as-usual across the industry? This initiative will be developed in part through crowd-sourcing contributions from community experts. We will share how anyone can contribute to the manuscript content (with credit acknowledged where applicable). By capturing the current state of knowledge, we aim to address common questions shared across the industry. By working collaboratively and openly, we hope to get a wide range of input from many different facets of the industry. Presenter Biography Michael Rimler currently serves as Strategic Integration Lead within Vaccines Biostatistics at GSK. He has over 13 years of experience in the pharmaceutical industry, providing technical, analytical, and leadership support to clinical reporting teams. Prior to joining GSK, Michael worked for a number of CROs and, in a previous life, served on the faculty of Xavier University as an Assistant Professor of Economics. Michael launched the GSK Clinical Programming’s R Adoption initiative in 2019, working closely with the broader R initiatives for Biostatistics led by GSK’s Data Science group. Michael is passionate about easing pain points of conventional clinical reporting workflows. This includes exploring opportunities to capitalize on open-source solutions, discovering ways to leverage metadata to increase quality and efficiency of production flows, and reimagining how we interact with our data through linked data models. Michael serves on the PHUSE Board of Directors as the Open-Source Technologies Director. He is a co-founder and current Council member for pharmaverse and was the Chair of the 2023 PHUSE US Connect in Orlando, Florida.