
Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.

April 26, 2021
As we all continue to take necessary precautions against the spread of COVID-19 virus, this year again the CDISC EU...
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January 28, 2021
A little walk in the CDISC Library, hand in hand with SAS
The Christmas break presented an opportunity to make my first concrete steps into the CDISC Library. Overall, it was a...
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December 18, 2020
Submitting Software Programs to the Regulatory Agencies
Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit...
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November 23, 2020
Data Standards and Submission Highlights from PHUSE EU CONNECT 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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October 28, 2020
When your ADaM package is not traceable back to SDTM
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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September 14, 2020
From Before to After: Preparing and Concluding your FDA Data Submission
“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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July 28, 2020
Therapeutic Area User Guidance – The hidden Gems
CDISC standards have been around for a while with the first SDTM Standard version released in 2004. However, it was...
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June 29, 2020
The Good Data Submission Doctor: CDISC for COVID-19
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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April 27, 2020
Highlights from the 2020 Virtual CDISC EU Interchange - Part 2
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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April 24, 2020
Highlights from the 2020 Virtual CDISC EU Interchange by Angelo Tinazzi
In early March, when countries around the world started implementing lockdowns, the European CDISC Committee (E3C)...
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October 23, 2019
The Good Data Submission Doctor - New ADaM Implementation Guidance
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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