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.
November 12, 2020
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.
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