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"In a clear presentation it gave a perfect insight into our struggle with SDTM and legacy data"


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Conference 2009 - Keynote Presentation

Dr. Diane Jorkasky gave a highly relevant, provocative and out-of-the-box-thinking keynote speech at this year’s conference which has been cited and mentioned in many subsequent presentations throughout the whole event.

Here is a short list of bullet points to summarise her points:

  • The key asset of any pharmaceutical company is the data. Without clinical data, no compound will make it to the market, no matter how good it is.

  • Currently the industry is not using the data to its full potential

  • Well organized, structured and easily accessible data-depositories built on a compound level are rare

  • Consequently retrieving any kind of information over a whole compound (i.e. al patients who ever took the drug during a study) is extremely time consuming and costly, if not impossible. This because of non-standard data models, legacy servers residing on legacy servers, etc...

  • Usage of placebo data within a therapeutic area across compounds is hardly possible. Companies have to buy expensive placebo data to circumvent this incapability of using the already available data

  • Using pre-clinical data for better prediction of an optimal dose for Early Development studies could save a lot of time and effort.

    • Dr. Jorkasky proposes three strategies to improve this situation

      • Drive standards

      • Drive technologies

      • Drive new ways of doing the business process

The video shows examples and success stories for each one of these points.