Creating Efficiency with Metadata-Driven End-to-End Standards, Upcoming Webinar Hosted by Xtalks

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In this free webinar, the featured speakers from PRA Health Sciences will describe the FDA and PMDA requirements for metadata-driven standards and show how, from data collection to analysis, they can be described as linked metadata in order to drive automations. Through a case study, attendees will learn how implementing end-to-end standards can lead to reduced efforts in tasks from database build to SDTM Mapping, as well as tables, figures and listings development.

The panelists will also show how through these standards they were able to decrease their effort per unit for various tasks in the process, and will offer recommendations for how the attendees can achieve similar benefits through their end-to-end standards implementations.

The FDA and PMDA are now requiring standardized study data in submissions. PRA Health Sciences has worked to create metadata-driven end-to-end standards to comply with these regulatory requirements and to drive efficiency, consistency and quality of its delivery.

In this webinar, panelists from PRA will demonstrate, through a case study, how they have defined end-to-end standards as interconnected metadata and developed automations to create Case Report Forms, SDTM, and ADaM data sets and tables, figures, and listings. The panelists will also show how through these standards they were able to decrease their effort per unit for various tasks in the process, and will offer recommendations for how the attendees can achieve similar benefits through their end-to-end standards implementations.

Join experts from PRA Health Sciences for the live webinar on Wednesday, December 2, 2020 at 11 a.m. EST / 4 p.m. GMT:

  • Kent Letourneau, Executive Director, Global Data Standards
  • Hansjörg Frenzel, Senior Principal Clinical Data Standards Consultant
  • Maria Sekac, Senior Principal Clinical Data Standards Consultant

To register for this event, visit - Creating Efficiency with Metadata-Driven End-to-End Standards.

ABOUT PRA HEALTH SCIENCES

PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, Africa, Australia and the Middle East and more than 17,500 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit http://www.prahs.com.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Sydney Perelmutter
Xtalks
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