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"interesting to hear views on the subject"

Roche

Mar
01

Overcoming "Frühjahrsmüdigkeit"

  • Farhana Khan
  • 01/Mar/2012 00:00
Just in case you all decide to rush off and enter "Frühjahrsmüdigkeit" in google to work out what it is that I am talking about, let me save you the hassle. Literally translated it means something like "spring tiredness"! According to toytowngermany.com Frühjahrsmüdigkeit is another peculiar medical disorder suffered exclusively by Germans! I of course have to disagree.
Aug
15

What Model Are You? Exploring the different working structures that exist to support SDTM development

  • Joanna Koft
  • 15/Aug/2011 08:00
As our industry standard of regulatory submissions shifts towards CDISC-compliance, sponsors must adopt new processes to support the shift. With the implementation of the submission standards of SDTM, ADaM, and Define.xml, this adds up to a plethora of new processes and responsibilities. SDTM alone encompasses many of these new processes….including new tasks such as SDTM annotation of CRFs, creation of SDTM metadata specifications, programming of SDTM datasets and parallel programming/QC of SDTM datasets. This puts additional pressures on groups such as statistical programming to be able to efficiently get their work done while adhering to new data standards.
Jul
15

The Standards Train

  • Daniel Boisvert
  • 15/Jul/2011 07:28
People always talk about the “Standards Train.” Get on the standards train, have you missed the standards train?
May
16

Playing a game of telephone: Should non-regulatory professionals attend regulatory meetings with FDA?

  • Joanna Koft
  • 16/May/2011 14:09
2011….A very different scene to me in the world of statistical programming in biotech since I began in this field 11 years ago. Sure, the bottom line still remains the same…programmers are still programming using SAS, working towards tight deadlines with quick turnarounds once databases lock. However, we (or most of us anyway) have climbed aboard the clinical data standards train, getting on and off at different stops along the way.
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