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

January 28, 2021
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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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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October 1, 2018
Details Matter When Submitting CDISC Packages to Authorities
One of my wife’s favorite TV shows is ‘Quattro Ristoranti’ (Four Restaurants). In each episode of the show, 4...
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February 6, 2018
Life in Programming: Interview With Ajay Sathe
We were excited to learn recently that Ajay Sathe, the CEO of our India Operations, was awarded lifetime honorary...
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