To request a copy of the webinar presentation, please contact: get_started@pointcross.com
Abstract
The FDA is using NIMS (Nonclinical Information Management System) to perform data fitness checks and to review sponsor submissions that must conform to the Agency’s implementation of the CDISC SEND standard.
Sponsor submitted studies in PDF or non-standardized electronic formats considered to be pivotal by reviewers are additionally being standardized and loaded into NIMS by PointCross under a contract with the FDA.
With NIMS, reviewers now have the ability to analyze study data in more depth and to be able to more readily detect safety signals. Sponsors should assume that as the FDA and other regulatory authorities continue to expand their repository of digital studies, they will have the ability to conduct analysis within and across studies, species and submissions to advance regulatory sciences and reviews.
If you are a sponsor interested in accelerating data standardization of planned submissions, gaining knowledge of the systems and processes needed to implement upcoming FDA mandated standards, and understanding how reviewers may analyze standardized study datasets, you would be interested in this webinar. We discussed the following topics:
- The FDA’s implementation of NIMS built on the PointCross DSIMS® product
- Analytics and visualization of standardized data using the same tools available to reviewers
- Benefits of standardizing completed studies in preparation for an IND or NDA submission
Panelists
- 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