Foster City, CA
Building High-quality Clinical and Non-Clinical e-Data
Submissions for FDA Review


Summary:

PhUSE, hosted by PointCross held the final US SDE of 2015 in Foster City, California on December 2nd.

Eight accomplished speakers shared lessons learned, best practices, operational governance frameworks and business processes from their diverse experience in implementing CDISC compliant submission initiatives.

A recurring topic was the importance of establishing the right processes for assurance of data quality, consistency and sufficiency. The need for these areas to be addressed became particularly evident when the FDA presented data loading statistics from their Janus CTR initiative. As high as 77% of SDTM datasets submitted to the agency during 2014 and 2015 failed to load at the first attempt. Overall, 60% of studies either did not load into the CTR or had major blocking issues. We believe that this event raised awareness as to why getting it right matters both to sponsors and the agency and provided attendees with practical insights about how these needs can be addressed.  

Presentations: 

Welcome SDE Co-Leads

Optimizing Standards Implementation for Successful e-data Submissions to the FDA
– Dhananjay Chhatre, Gilead

Standardizing Data Cuts Mercidita Navarro, Genentech

Common Errors in Loading SDTM Data to the Clinical Trials Repository and Why Getting it Right Matters Crystal Allard, FDA

A Need for Prescriptive Define.xml Sergiy Sirichenko, Pinnacle 21

PhUSE–FDA Working Group on Standardizing Data Elements for the Site Selection Process
Patty Gerend, Genentech 

SEND Compliance – Challenges and Opportunities for Sponsors Sandor Schoichet, Meridian Management Consultants

Non-clinical Study Data Specifications and CRO-Sponsor Workflows for FDA SEND Compliance
Kristi Johnson, PointCross Life Sciences & Michael Dorato, Smithers Avanza

Brochure:

Download the brochure here.

SDE Co-Chairs:

If you have any questions, or require any additional information please contact the SDE Co-Chairs. 

Shree Nath, PointCross

Lyn Fenex, Experis

Sponsors: