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© d-Wise 2013 May 20, 2015 Page 1 May 20, 2015

SAS Drug Development (SDD) Version 4 System … 2015 SDE Presentations/Challenges o… · The standards are a good start, ... around the science coupled with the rigidness of ETL

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© d-Wise 2013 May 20, 2015 Page 1

May 20, 2015

© d-Wise 2013 May 20, 2015 Page 2

Over 18 Years SAS Experience

– PAREXEL

– Takeda

– Lilly

– Dootsonic

– d-Wise

– + others…

PhUSE Committee member

Coding Solutions Stream Chair

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What is driving your process?

– Is it the science?

– Or is it the standards?

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Study Design

Data Collection

Data Management

Statistical Programming

Statistics

Reporting

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The problem is the dream we have been sold of standards, of tools that can ease our pain by automating the whole process.

The standards are a good start, the tools are effective. But you cannot have infinite flexibility around the science coupled with the rigidness of ETL tools and expect it to be smooth sailing.

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Metadata Driven Systems

RDF / Direct Graphs

Evolution of Standards

Flexibility and management of standards