Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
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
Watch out, the FDA Rejection Criteria are Now in Place
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
CDISC SDTM and ADaM: An Explosive 2021 Ending!
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” Process
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
The Importance of Traceability
Traceability is crucial in all steps of clinical data handling, from data collection to final analysis. The importance...
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July 30, 2021
In a Virtual Room with the FDA Reviewers
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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March 30, 2021
The Integration Dilemma
As of today, our Industry has not defined any approach, nor does an official regulatory agency...
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February 24, 2021
Avoiding Lost-in-Translation with Submission Terminology
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
A little walk in the CDISC Library, hand in hand with SAS
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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July 28, 2020
Therapeutic Area User Guidance – The hidden Gems
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
The Good Data Submission Doctor: CDISC for COVID-19
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
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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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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November 27, 2018
The Good Data Submission Doctor: 5 Top ADaM Frequently Asked Questions
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
The Good Data Submission Doctor: 5 Top SDTM Frequently Asked Questions
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
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, 2017
The Making of a CDISC Trainer
CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher...
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November 14, 2016
Infographic: 9 Do's and Don'ts to Ensure Independence of QC
In our last blog, we shared some of Angelo Tinazzi and Cedric Marchand's recommendations on how to ensure independence...
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August 2, 2016
The CRO role in Data Standards Governance
Editor's note( this blog was refreshed in April 2018) As CDISC compliant submissions become increasingly expected,...
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May 12, 2016
Lost in Traceability- From SDTM to ADaM
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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