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"getting FDA at conference was a great addition"

AstraZeneca

PhUSE SDE - Redwood City, CA



Summary:

The PhUSE Redwood City SDE took place on September 26th 2013 at AbbVie Corporation and was a great success with over 45 people in attendance.

Theme:

Open-Source Analytics in Drug Development Process

There are many software applications and widgets to analyze data in the drug development process. While SAS® is the standard for statistical programming and analysis of clinical data, many organizations are trending to embrace open source tools or "apps" to support specific needs. While there has been hesitation to use open source software, such as validation, Part 11 compliance and the programming learning curve.

SAS®, Medidata and other commercial platforms have embraced open (platform) programming to provide users a framework to build tools and share technology.  As a result, robust software and processes have been developed and distributed and are rapidly being embraced by drug development organizations.  Today's discussions are focused on how exploring different platforms and open source development opportunities are dependent to the evolving needs at academic and commercial levels.

Presentations:

The Use of R in Biomarker Data Analysis

- Nusrat Rabbee, inVentiv Health Consulting

Distribution Methods of Clinical Open Source Programs

- Rick Morrison, Comprehend Systems 

How Commercial Platforms can Encourage Open Source Software Development

- Evan Hahn, Medidata 

FDA/PhUSE CSS Working Group: Open Code Repository

- Hanming Tu, Accenture 

Managing 21 CFR Pary 11 Compliance: Using Checksums on Open Systems

- Carey Smoak, Roche Molecular Systems 

Operation: Validate R

- Matthew Davis, Theorem Clinical Research


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