Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
December 27, 2023
Perspectives covers a wide range of topics related to data submission and data integration, from ISS and ISE best...
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December 15, 2023
The Value of an Optimized Clinical Data Strategy: How Small Changes Can Make a Big Difference
In clinical trials, high-quality data is essential. It drives the drug development decision-making process and is a...
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December 8, 2023
Discussions with the FDA and Ensuring Data Submission Success
Regular technical discussions with the FDA play a critical role in ensuring data submission success. These discussions...
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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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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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