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

Hays Pharma

May
15

Got TMF?

  • Greg Fagan
  • 15/May/2012 01:00
Before I start – I just want to emphasize that everyone is entitled to at least one boring Blog post. Well, this is mine. Apologies up front. I did have good intentions, however. I was even going to start it off with some experiences I had in the jungles of South America...
Nov
01

Statistical Programming more than just SDTMs and ADaMs

  • Greg Fagan
  • 01/Nov/2011 14:33
I am a Statistical Programmer, here me roar! That statement sounds very bold and confident; however, to be honest, I am not sure what a Statistical Programmer does anymore. This post may be rehashing some previous topics about specializing or not – but I will try not to be redundant. I want to speak about Statistical Programming – proper.
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.
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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