Perspectives on Enquiry & Evidence

Cytel's blog featuring the latest industry insights.

Featured post

How to Ask the Right Questions at an Authority Meeting

As a drug developer, you have to live with the answers and comments you get from regulatory authorities. Therefore, it’s essential that you choose your questions carefully and avoid questions you don’t need answers to. Here we take a closer look at how to approach these meetings.

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Perspectives on Enquiry and Evidence

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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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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March 7, 2019

The Good Data Submission Doctor - CDISC Stupidario

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January 22, 2019

Misuse and Misunderstanding of using CDISC Controlled Terminology

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December 5, 2018

Creating a Common Language: Forging Statistical and Clinical Collaborations

In this blog, Paul Terrill, Director of Strategic Consulting at Cytel outlines his blueprint for ensuring smooth...

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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 10, 2018

When Knowledge Drives Results: The Impact of a Winning Data Strategy

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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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December 21, 2016

CDISC submissions- are you up to speed?

December 18th 2016 was a significant date for the pharmaceutical industry and regulatory submissions. For trials which...

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December 20, 2016

How do CDASH standards build data quality?

Data Standards play a crucial role in structuring and promoting long term value of clinical data. Clinical Data...

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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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March 8, 2016

Mind the Gap! How to prepare for SDTM migrations.

Data standardization is critical to ensure successful regulatory submissions. While many sponsors now choose to create...

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