Streamlining Study Submissions for Success: An Integrated Summaries of Safety (ISS) Case Study with Urovant Sciences, Upcoming Webinar Hosted by Xtalks

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In this free webinar, the featured speakers will discuss key considerations when selecting an ISS/ISE provider and best practices for submission deliverables utilizing an outsourced model for Module 5. Attendees will hear about the lessons learned for analysis and programming and the technology platforms that facilitate analysis and submission readiness/review.

The talk will highlight how eClinical and Urovant worked collaboratively for more than a year and how data was centralized across numerous legacy studies for faster access.

Clinical development has more partnerships and collaborations than ever before with many companies acquiring assets from others and building centers of excellence and expertise through late-stage development and submission preparation. This webinar will present a case study on the submission planning process including data analysis, collaboration process, and technology platforms leveraged to deliver the Integrated Summary of Safety (ISS) deliverable for the Urovant Gemtesa (Vibegron) FDA submission.

The webinar will cover these topics from both the Urovant and the eClinical perspectives including the development and review of the Statistical Analysis Plan, the mapping and up-versioning to current SDTM standards and practices utilized. The talk will highlight how eClinical and Urovant worked collaboratively for more than a year and how data was centralized across numerous legacy studies for faster access.

The webinar will also highlight how to structure, coordinate and manage an effective team with various dependencies utilizing a combination of both internal and external resources to collectively work on submission deliverables. Lessons learned across planning, process, execution, team structure, collaboration, dry runs and the final submission will be analyzed.

Join Demi Niforos, Vice President, Biostatistics and Statistical Programming, eClinical Solutions and Denise Shortino, Sr. Director, Biostats, Programming and Data Management, Urovant Sciences in a live webinar on Thursday, June 10, 2021 at 10am EDT (3pm BST/UK) to hear expert speakers with years of statistical analysis, programming and submission experience share the knowledge and skills needed by submission preparation team members to ensure success and manage risk associated with submission deliverables.

For more information, or to register for this event, visit Streamlining Study Submissions for Success: An Integrated Summaries of Safety (ISS) Case Study with Urovant Sciences.

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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