Perspectives on Enquiry & Evidence

Cytel's blog featuring the latest industry insights.

Featured post

Innovative Clinical Trial Design: Commercial vs Open-Source Software? Why Not Both?

In the ever-changing field of clinical trial design, there is often a need to evaluate design options quickly and efficiently. But when it comes to evaluating options, which is better: commercial or open-source software? And does it need to be a question of either-or?

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Perspectives on Enquiry and Evidence

March 26, 2020

Cytel's Response: EMA Points to consider on implications of COVID-19

Further regulatory guidance has been released concerning the implications of the Coronavirus disease (COVID-19) on...

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March 23, 2020

Cytel's Response: EMA Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic

On March 20th the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA)...

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March 19, 2020

Cytel's Response: FDA Guidance on Conduct of Clinical Trials during the COVID-19 Pandemic

The FDA issued a guidance yesterday on how the COVID-19 Pandemic may affect the conduct of clinical trials. Below are...

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October 23, 2018

Career Perspectives: Interview with Munshi Imran Hossain, Senior Data Scientist

Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and...

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September 20, 2018

Career Perspectives: Interview with Adam Hamm, Director of Biostatistics

At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking...

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August 23, 2018

Career Perspectives: Interview with Meredith Alm, Manager, QA Compliance

Cytel has grown significantly over the last 30 years, with operations across North America, Europe, and India. All of...

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July 6, 2017

When Biostatisticians Disagree About Ethics

By Esha Senchaudhuri The ethical benefits of adaptive clinical trials have been widely acclaimed: higher prospects for...

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June 28, 2017

Under wraps: the importance of patient privacy

About the Author: Manjusha Gode has over 28 years' IT experience spanning delivery Management, quality management,...

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April 28, 2017

Case Study: Redesigning a Pragmatic Trial in Oncology

In this blog we share a case study in which our statistical consulting team helped a client redesign an oncology...

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February 27, 2017

Estimands 101: Interview with Mouna Akacha

It’s been hard to miss the prevalence of estimand-related discussions in the last year. This is a topic which is very...

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January 23, 2017

How to get the regulatory green light for your adaptive design?

As a group, Cytel had over 40 successful regulatory interactions last year, many of which supported approvals for...

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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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August 9, 2016

Operational and regulatory considerations in a promising zone trial

At the recent JSM Meeting, Cytel’s Yannis Jemiai presented the case study of the VALOR trial which used a promising...

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June 5, 2015

Building Teams to Handle Unexpected Regulatory Agency Requests

Not long ago, one of our clients submitted Phase 2 and Phase 3 data for a new rare disease drug which had received...

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February 17, 2015

How Proposed Regulatory Reforms Will Affect Your Clinical Trial

21st Century Cures (also called Cures2015) is a bipartisan initiative undertaken by the Committee on Energy and...

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September 25, 2014

Part II: The Philosophy Behind a Software Package

A few weeks ago, we posted a synopsis of an event held at ISCB Vienna in which statisticians from Cytel, SAS and Stata...

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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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April 24, 2014

New JAMA Study Confirms Importance of Trial Design for FDA Approval

Here at Cytel we firmly believe that if you don’t get the design of a clinical program right, then nothing else...

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