Publications: Presentations

Author: John Brega, PharmaStat, LLC, Newark, CA
Date: Tuesday, June 10th, 2014
Presented at: Bay Area CDISC Implementation Network

We frequently give this presentation to new clients, to let them know what to expect when planning a submission. Topics of this conversation include:


  • Strategy and planning
  • Specifying project deliverables
  • Production and QC of analysis datasets and TFLs
  • Evaluation of project deliverables
  • Assembling and auditing the data submission
  • Fielding FDA requests
  • 120 Day Safety Update
  • Preparing for the Advisory Committee meeting

Author: John Brega, PharmaStat, LLC, Newark, CA
Date: Wednesday, July 24th, 2013
Presented at: Bay Area CDISC Implementation Network

This presentation de-mystifies the Define.xml 2.0 documentation standard by:

  1. Introducing the new features in Define.xml 2.0 with examples of familiar problems they solve
  2. Comparing display-formatted documentation from 2.0 with1.0 for a variety of use cases
  3. Pointing out challenges in collecting metadata content for the new features
  4. Discussing methods for managing user-editable content

Author: Linda Collins
Date: Tuesday, September 25th, 2012
Presented at: PhUSE Single Day Event, San Diego

The ODS Statistical Graphics package contains a powerful set of graphical elements. One especially useful feature of this package is the way that these elements can be combined.  With small changes in syntax, one can present several different kinds of information on a single graph, or use a layout as a prototype for a set of related graphs. This presentation will show some examples of techniques for combining various types of graphs – line graphs, series, bar charts or sets of text entries – into a coordinated presentation.


Author: Micaela Salgado-Gomez, PharmaStat, LLC, Newark, CA
Date: Thursday, November 3rd, 2011
Presented at: San Diego CDISC User Network Meeting, San Diego November 2011

This presentation discusses the Common Data Standards Issues Document issued by CDER which describes reviewer’s experience with submitted SDTM data , recommendations for standard data preparation, and the impact of the recommendation on SDTM and ADaM preparation.