What are you waiting for? The FDA can review your data in ways you can’t

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

Abstract

The FDA is already using NIMS (Nonclinical Information Management System) to receive and review submissions in standardized formats that must conform to the CDISC SEND standard and the FDA’s Nonclinical Validator Specifications.

Submitted studies considered pivotal are being standardized and loaded into NIMS for use by reviewers under an FDA contract with PointCross.  This webinar covered the following topics:

  • Our data standardization service used by the FDA and industry to standardize studies
  • How we validate your datasets to warrant fitment with the FDA’s Nonclinical Validator Rule Specifications, and
  • How you can review studies using PointCross’ DSIMS software, the same tool used deployed at the FDA as NIMS and used today by reviewers

Panelists

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

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