August 25, 2023
For several years, CDISC and Regulatory Data Submission expert Angelo Tinazzi has authored the series, The Good Data...
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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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June 2, 2023
Data submissions are very regulated, but every drug and drug development are different. Therefore, the data presented...
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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 26, 2023
Regular technical discussions with the FDA play a critical role in ensuring data submission success. These discussions...
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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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February 11, 2022
Adopting data standards such as CDISC in the early phase of clinical drug development contributes to the consolidation...
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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 23, 2021
Cytel blogs bring you debate and discussion of the newest trends in statistics and quantitative strategy. In 2021, our...
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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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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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March 30, 2021
As of today, our Industry has not defined any approach, nor does an official regulatory agency...
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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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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 21, 2020
2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog...
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September 14, 2020
“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
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
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
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
In early March, when countries around the world started implementing lockdowns, the European CDISC Committee (E3C)...
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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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June 27, 2019
By Nicolas Rouillé and Eric Henniger The right design and the right data ultimately leads to the right decisions, so...
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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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January 9, 2018
Our Career Perspectives' series is back! Cytel has industry-leading experts in statistical programming with years of...
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June 28, 2017
About the Author: Manjusha Gode has over 28 years' IT experience spanning delivery Management, quality management,...
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May 17, 2017
This new case study shares how Cytel supported a specialist biopharmaceutical company from Phase 2 trial design through...
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February 6, 2017
CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher...
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December 21, 2016
December 18th 2016 was a significant date for the pharmaceutical industry and regulatory submissions. For trials which...
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December 20, 2016
Data Standards play a crucial role in structuring and promoting long term value of clinical data. Clinical Data...
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August 2, 2016
Editor's note( this blog was refreshed in April 2018) As CDISC compliant submissions become increasingly expected,...
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July 25, 2016
Statistical programmers are in high demand within the biopharmaceutical industry, and within the dynamic world of...
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May 12, 2016
Once upon a time Hansel and Gretel laid a trail of breadcrumbs which they followed to find their way back home. Their...
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March 8, 2016
Data standardization is critical to ensure successful regulatory submissions. While many sponsors now choose to create...
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