This webinar will present a case study on the submission planning process including data analysis, collaboration process, and technology platforms .. Read more leveraged to deliver the Integrated Summary of Safety (ISS) deliverable for the Urovant Gemtesa (Vibegron) FDA submission. Urovant acquired the Vibegron asset mid-way through development and worked with eClinical Solutions on the submission deliverables and utilized the elluminate® clinical data platform as a core centralized repository. The topics presented will include why Urovant selected eClinical as their ISS partner and how Urovant and eClinical collaborated to surpass their target timelines and produce a final deliverable to the FDA. 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 original site for employees in the pharma, medical, diagnostic and related industries. Join thousands of other professionals from life science, medical device and food industries.
- Share your Experience