Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
February 23, 2024
Written by Angelo Tinazzi, Nicolas Rouillé, and Sebastià Barceló In the realm of standards management, companies of all...
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January 3, 2024
New FDA Data Submission Requirements and Substantial Changes
Ten years ago this month, in January 2014, the FDA issued the first version of its Technical Conformance Guide (by...
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December 27, 2023
Top Data Submission and Data Integration Posts of 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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November 1, 2023
The Changing Landscape of the Pharmaceutical Industry: A Preview of Cytel’s Contributions at PHUSE EU 2023
It feels like just yesterday I attended my first PHUSE conference back in 2005 in Heidelberg, Germany. Fast forward 19...
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October 23, 2023
Experiencing the CBER: Anticipating Unique Challenges
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the...
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October 18, 2023
Preparing Your Integrated Summaries of Safety and Effectiveness: Best Practices
Written by Angelo Tinazzi and Florence Le Maulf Integrated Summaries of Safety (ISS) and Integrated Summaries of...
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August 25, 2023
Preparing and Concluding Your FDA Data Submission, and More Insights on Data Submission and Data Integration
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
The Evolution of Open-Source Initiatives and New Standards Development for the Data Submission of the Future
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
Standards and Open Source Hand-in-Hand: Leveraging Automation to Expedite Drug Market Request Review Process
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
Presenting Clinical Data for Regulatory Submission: A Stats Perspective
Data submissions are very regulated, but every drug and drug development are different. Therefore, the data presented...
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May 24, 2023
It’s Time to Move, Time to Move to Define-XML 2.1
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 25, 2022
Insights on the New ADaM guidelines and Europe Interchange 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
WINTER WEEKEND READ: Tops Tips and Tricks from the Good Data Doctor
Adopting data standards such as CDISC in the early phase of clinical drug development contributes to the consolidation...
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