Working Group Scope

A collaboration working to improve nonclinical assessments and regulatory science by identifying key needs and challenges in the field and then establishing an innovative framework for addressing them in a collaborative manner through limited term projects.

Our focus is on using informatics approaches and standards for delivering ideas and solutions to nonclinical data challenges. Annually, at the Computational Sciences Symposium (CSS), we present our progress and achievements and develop new projects that further the value of nonclinical data.


Current Projects 

Harmonization of SEND Implementation to Enable Historical Control Data Analysis

SEND Industry Feedback Survey

Nonclinical Script Assessment

Nonclinical Study Data Reviewers Guide

SEND Dataset QC Best Practices

SEND Implementation User Group


Susan DeHaven: Working Group Lead

susan.dehaven@sanofi.com


Patricia Brundage: Working Group Lead

patricia.brundage@fda.hhs.gov




Resources 

CSS 2020 

For a list of previous accomplishments and completed projects, click here