August 14, 2023
In the first part of this post, I discussed the ongoing revolution, or maybe I should say evolution, we are living...
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August 9, 2023
How do you envision the future of data submission? Last week, I had the privilege of presenting the topic “Standards...
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May 24, 2023
As of March 2023, specifically for any study started on or after March 15, 2023,1 for the submission of SEND, SDTM, and...
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April 21, 2023
It was early March 2020, after the world was hit by the Covid-19 pandemic, that those of us on the CDISC Eu committee...
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February 8, 2023
Over the past years, probably the entire last decade, there have been several discussions on how to handle multiple...
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December 9, 2022
As promised in my last post prior to PHUSE-EU Connect, I’d like to now share some reflections on my “Integration...
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November 8, 2022
Although many of you can’t wait for the start of the Football World Cup 2022 (less than two weeks while I’m writing),...
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September 16, 2022
In the first part of this article, I raised awareness of the availability of additional FDA guidances containing CDISC...
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June 15, 2022
For years CDISC data standards implementers have struggled to find good implementation examples and use cases beside...
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April 25, 2022
I am excited to see you all at the CDISC Europe Interchange, April 27 – 28 but unfortunately, it will be a virtual...
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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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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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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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October 5, 2021
Traceability is crucial in all steps of clinical data handling, from data collection to final analysis. The importance...
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August 31, 2021
For years, I have been telling the recruiters at Cytel to be wary of candidates claiming to have a CDISC Certification...
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July 30, 2021
I had recently (for the first time) the pleasure and honor to attend a virtual meeting with the FDA, a pre-NDA Type-B...
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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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November 27, 2018
This is the third in our blog series ' The Good Data Submission Doctor' in which Angelo Tinazzi, Director of Standards,...
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November 1, 2018
In this second post of the “Good Data Submission Doctor” ( read my first post The Master Recipe: Quality and Attention...
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October 1, 2018
One of my wife’s favorite TV shows is ‘Quattro Ristoranti’ (Four Restaurants). In each episode of the show, 4...
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