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

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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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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