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"getting FDA at conference was a great addition"


PhUSE East Hanover Single Day Event (SDE)

The East Hanover Single Day Event which took place at Novartis on Wednesday June 13th 2012, was a great success with over 70 PhUSE members in attendance. 


The CDISC standards were introduced over the decade ago with the goal of standardizing our clinical data and improving efficiencies in our process thus leading to faster approval times.  The next step in that evolution would be the introduction of automated and generic, reusable code modules to leverage those standards and speed up the development process. 

At the PhUSE Single Day Event in New Jersey, we will learn how a number of companies have leveraged standards, metadata, and tools to improve the process and discuss what challenges still exist in terms of development and maintenance of such tools, but also the challenges of people change management to this new way of working.


Click on the links below to download the presentations from the day

Cost Effective Standards Implementation: A New Paradigm for the Drug Development Life Cycle Jeff Abolafia, Rho Inc & Frank Dilorio, Code-Crafters

Legacy data Conversion - A Practical Example: Oncology

Niels Mathiesen, mathiesen & mathiesen

SCR (Standards Clinical Reporting) A Metadata Driven System

Andre Couturier, Novartis

Penalities of Not Using metadat to Generate Reports

Eric Kammer, Novartis Oncology

GThe Use of Metadata in Creating, Transforming and Transporting Clinical Data

Gregory Steffens, Novartis

Need for Human Involvement in Checking for Compliance of Both SDTM and ADaM

Sandra Minjoe, Octagon Research Soltuions

FDA/PhUSE - CSS Workgroup Update

Chris Decker, d-Wise Technologies

Download the brochure HERE

PhUSE would like to thank the event sponsors: