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

Hays Pharma

Nov
15

The “Standard” Deviation: When is it OK to Stray?

  • Joanna Koft
  • 15/Nov/2011 08:00
At this stage in the game, I think we, as sponsors, have finally moved from “if we have to implement standards” to “how we should be implementing standards”. As it turns out, I think we can all agree that the latter is much more challenging. Standards such as CDASH, SDTM and ADaM are available for our implementation pleasure….along with a new set of challenges. Sponsors must take the data models and implementation guides and apply/integrate them into their own processes. Sounds easy enough, no?
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