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: