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Clinical Information Strategy: How to Learn More From Legacy Studies to Support Your Current Research

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Presented by Dr. Joshua Sharlin, Tuesday April 24, 2007, 1:00 p.m. to 2:30 p.m. EDT (GMT -4) You’ve spent hundreds of millions of dollars and tens of thousands of hours collecting and analyzing data needed to support your product’s approval. After submission to FDA, how can you learn new information from your completed studies to support existing projects and increase the efficiency of on going research efforts?

Clinical information strategy is a new area of interest among FDA-regulated companies. It offers techniques and strategies that can be used mine additional value from past clinical studies. Given the large investment in data from legacy studies and the huge cost of new research, companies know they must develop ways of creating more knowledge from old information.

On Tuesday, April 24, at 1:00 pm EDT, join FOI Services, Inc. and Dr. Joshua Sharlin for a ninety-minute teleconference to explore the organizational issues that should be addressed and the technical problems to be solved to access and combine data from past studies to learn new information. In addition to looking at the issues involved, Dr. Sharlin will interview Paul Loughlin from AstraZeneca to examine how a large pharmaceutical firm approached this important topic. To explore the intricacies of data handling, Dr. Sharlin will interview Don Henderson an expert on extracting information from data using SAS. Take advantage of the expertise of these industry professionals -- this teleconference will benefit any company with a need to get more information from their legacy data.

What You'll Learn:

  • Types of information that can learned from legacy studies and how it can be used
  • Organizational issues to be solved when starting a clinical information strategy effort
  • Impact on your information technology infrastructure
  • How to promote information sharing within a company
  • Methods of continuous improvement
  • Issues when outsourcing your clinical information strategy
  • SAS programming techniques
  • Plus much, much more…

What You’ll Get:

  • Insight from presenters with clinical information strategy experience
  • Sample SAS code
  • Explanations for how to modify the SAS code to fit your needs
  • Information you’ll need to develop or improve your clinical information strategy
  • Time for questions and answers

Your Presenters:

  • Joshua Sharlin, Ph.D., president of Sharlin Consulting, is a former FDA reviewer and has trained tens of thousands of people from hundreds of FDA regulated companies on how to enhance their regulatory processes and improve submission content and organization.
  • Don Henderson has over 30 years of SAS consulting experience and specializes in data mining, data warehousing and data migration. His experience includes over 10 years at SAS including, in part, starting and managing the SAS Consulting Services subsidiary for SAS Institute. His new book "Building Web Applications with SAS/IntrNet: A Guide to the Application Dispatcher" will be available next month from SAS Institute Press.
  • Paul Loughlin, Director of Clinical Information Strategy at AstraZeneca, UK. For that last four years Paul has been developing and improving the AstraZeneca’s clinical information strategy. In this seminar Paul will contribute his insight and lessons learned AstraZeneca.

Who Should Participate? Anyone with a role in creating, improving or using the knowledge gained from legacy studies:

  • Clinical information specialists
  • Statisticians
  • Quality assurance/Quality Control personnel
  • Technical writers
  • Specialists in the execution and analysis of clinical trials
  • Information technology personnel
  • Scientific and medical staff

When: Tuesday, April 24, 2007, from 1:00 p.m. to 2:30 p.m. EDT (GMT -4)

Where: In your office or conference room

Register online or call 1-800-654-1147 (outside the US and Canada call +1-301-975-9400) to register by phone.