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Project Scope

Across the Pharmaceutical Industry worldwide there is a variety of understanding of SEND and approaches to SEND implementation. Generally, the larger companies have had the resources to follow SEND through its first announcement to the issuance of the SEND Guidance document which set the due dates for SEND to be used for submission of the studies started on or after the due date.

This project creates an electronic survey sponsored by PHUSE, with up to 15 multiple choice questions and an option to provide additional free text information. The survey is sent out to PHUSE members, requesting a 30 day response time, then the responses are compiled, distributed and made publicly available.



Project Leads

Email

Bob Friedman

bfriedman@xybion.com

Lou Ann Kramer

lkramer@cdisc.org

Janice M Fiori 

fiori_janice_m@lilly.com

Lauren White (PHUSE Project Coordinator)lauren@phuse.eu

CURRENT STATUS Q42020

Reviewing projects next steps after presenting at the virtual PHUSE/FDA CSS                                                                                  
Resources Type
2015 SEND Survey Results presented at the CSS 2016 event 
2016 SEND Survey Results presented at the CSS 2017 event 
2017 SEND Survey Results presented at the CSS 2018 event 
2018 SEND Survey Results presented at the CSS 2019 event 
2019 SEND Survey Results presented at the CSS 2020 event 

Key Milestones 

ObjectiveTimeline






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