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https://www.cytel.com/blog/watch-out-the-fda-rejection-criteria-are-now-in-place
January 25, 2022
In this blog, I share some experiences we recently had during an FDA submission Cytel performed for a sponsor after..
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test44
https://www.cytel.com/blog/cdisc-sdtm-and-adam-an-explosive-2021-ending
December 15, 2021
Recently, on November 29 I received an email from CDISC announcing an important update for both SDTM and ADaM CDISC..
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https://www.cytel.com/blog/the-fda-real-time-oncology-review-process-an-opportunity-challenge-for-sponsors
November 30, 2021
The FDA “Real-Time Oncology Review (RTOR)”[1] is an “FDA project started in 2018 to facilitate earlier submission of..
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https://www.cytel.com/blog/the-integration-dilemma
March 30, 2021
As of today, our Industry has not defined any approach, nor does an official regulatory agency..
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https://www.cytel.com/blog/avoiding-lost-in-translation-with-submission-terminology
February 24, 2021
In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM...
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https://www.cytel.com/blog/a-little-walk-in-the-cdisc-library-hand-in-hand-with-sas
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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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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test44
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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