Why aggregating disparate data sources into a single “Study View” is important for your FDA e-Data Submissions

To request a copy of the webinar presentation, please contact: get_started@pointcross.com

Abstract

We discussed how consolidating all the electronic data for a “Study” in SEND is not simple. There are several requirements for modeling the trial design, complying with formats and terminologies, and detailed reporting on variables that are not addressed by current data collection practices and LIMS.

Our experts covered what you need to consider, and why, as you prepare to comply with the FDA’s new requirements for e-data submissions.  We discussed the following topics:

  • How the FDA’s binding draft guidance for providing regulatory submissions of standardized study data will impact your current processes
  • Gaps between how data is collected today vs. what is required to create a composite study view
  • How DSIMS is used by Sponsors to prepare and review submission compliant dataset

Panelists

  • Gitte Frausing, SEND Work stream Leader and Principal Consultant at Data Standards Decisions Aps
  • Shree Nath, VP PointCross Life Sciences and Program Manager for NIMS at the FDA
  • Pranav Agnihotri, Program Lead for DSIMS deployments to the Industry

To request a copy of the webinar presentation, please contact: get_started@pointcross.com