
Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.

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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June 15, 2022
Raising the Awareness for Additional FDA Data Submission Recommendations (Part I)
For years CDISC data standards implementers have struggled to find good implementation examples and use cases beside...
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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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April 13, 2021
7 Steps to an Evidence Dossier for Wearables
There has been an increasing use of digital measures in drug development recently. New wearables technologies can help...
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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 25, 2021
Use of Wearables in Confirmatory Clinical Trials
The convergence of several distinct trends has made wearables an increasingly attractive option for use in confirmatory...
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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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February 11, 2021
The biostats and clinical overview of a growing clinical strategy
The past two years have witnessed a heightened interest in the use of wearables in clinical development. The unexpected...
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December 21, 2020
Year-End Roundup: Your Favorite Blog Posts of 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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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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December 1, 2020
Mapping the Landscape of COVID-19 Clinical Trials in the US
An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread. As...
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November 17, 2020
Role of Prediction and Causal Inference in Clinical Research
As a part of Cytel’s "New Horizons Webinar Series", Alind Gupta, Senior Data Scientist, presents case studies from his...
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October 13, 2020
Introducing Observational Studies – Three Trends for Statisticians
The combination of greater access to electronic health records, bigger electronic claims datasets, and the need for...
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October 12, 2020
Bayesian Statistics and FDA Regulatory Acceptability
Cytel and Novartis are together hosting a complimentary Bayesian Virtual Symposium and an Interactive 7-part workshop....
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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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September 4, 2020
Cytel Co-Founder Cyrus Mehta Presents at the Heart Failure Collaboratory, a Public-Private Partnership with FDA
On Friday September 11, Cyrus Mehta, co-founder of Cytel, will be delivering a talk to the Heart Failure Collaboratory,...
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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 29, 2020
Webinar: Transparent Machine Learning in Oncology
In our previous blog, we spoke with Alind Gupta, who works as a Machine Learning Researcher at Cytel in Canada. The...
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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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April 20, 2020
Interview with Alind Gupta: Transparent Machine Learning in Oncology
Cytel is hosting a webinar on Transparent Machine Learning in Oncology, on April 21, 2020. Our speaker, Alind Gupta,...
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March 31, 2020
Key Design Thoughts for Basket Trials and Umbrella Trials by Jay Park
Since 1953, when the discovery of the structure of DNA was made, we have seen great advancements in genomics....
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March 12, 2020
Interview with Jay Park: The present and future of Master Protocols
In September 2018, the FDA provided a draft guidance on master protocols reflecting an increased interest in these...
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December 18, 2019
Year-End Roundup: Your Favorite Blog Posts of 2019
With only two weeks left for this fabulous year to end, we would like to thank all our blog subscribers and new readers...
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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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September 7, 2018
Opportunities of FDA’s Innovative Trial Design Pilot Meeting Program
On August 29th 2018, the FDA announced (1) that it would be establishing a Complex Innovative Trial Design (CID) Pilot...
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October 27, 2017
Design Concept for Confirmatory Basket Trial Interview with Bob Beckman: Part 2
In this blog, we share the second part of our interview with Bob Beckman, about a design concept for a confirmatory...
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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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April 13, 2016
HTAs: Adjusting Overall Survival for Treatment Switch
We continue our series of blogs covering the expert presentations from the EAST User Group Meeting. Consultant Claire...
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May 15, 2015
Can You Reproduce Your Clinical Trial Results?
Imagine that it’s been three years since the completion of a trial, and that suddenly a regulatory body calls into...
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June 10, 2014
Cytel Weighs in on Strategies for Oncology Development
The FDA’s Tatiana Prowell (Breast Cancer Scientific Lead in the Office of Hematology & Oncology Products) recently gave...
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