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https://www.cytel.com/blog/submitting-software-programs-to-the-regulatory-agencies-what-should-you-know
December 18, 2020
Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit..
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https://www.cytel.com/blog/data-standards-and-submission-highlights-from-phuse-eu-connect-2020
November 23, 2020
The Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all..
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https://www.cytel.com/blog/risking-your-traceability-and-credibility-when-your-adam-package-is-not-traceable-back-to-sdtm
October 28, 2020
About three years ago, Cytel was helping a sponsor on a project where I had to conduct surveillance of some CRO..
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https://www.cytel.com/blog/preparing-and-concluding-your-fda-data-submission
September 14, 2020
“A good start is half the battle” (the Before) when submitting data to the FDA and there are a couple of cherries to..
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https://www.cytel.com/blog/therapeutic-area-user-guidance-the-hidden-gems
July 28, 2020
CDISC standards have been around for a while with the first SDTM Standard version released in 2004. However, it was..
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https://www.cytel.com/blog/cdisc-for-covid-19
June 29, 2020
From the time the COVID-19 outbreak was declared a pandemic, the number of studies conducted around the world to either..
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https://www.cytel.com/blog/highlights-from-the-2020-virtual-cdisc-eu-interchange-part-2
April 27, 2020
In the first part of this two-parts blog, I speak about how the European CDISC Committee (E3C) together with CDISC..
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https://www.cytel.com/blog/highlights-from-the-2020-virtual-cdisc-eu-interchange
April 24, 2020
In early March, when countries around the world started implementing lockdowns, the European CDISC Committee (E3C)..
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https://www.cytel.com/blog/new-adam-implementation-guidance
October 23, 2019
October 3, 2019 was an important day for the ADaM team as it marked the release of the ADaM Implementation Guidance..
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