Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
January 22, 2024
Regulatory guidelines outline all crucial studies and documentation that should be in place before a drug product can...
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December 29, 2023
The Top Most-Read Posts of 2023
What a year! Perspectives has explored a myriad of topics this year within clinical development — from adaptive trial...
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December 22, 2023
Top Therapeutics Development Topics of 2023
Perspectives covers a wide range of topics within therapeutics development from advice on regulatory submission to...
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November 29, 2023
Don’t Forget the Development of Your Placebo: Overcoming Common Obstacles
A clinical trial is usually performed using some kind of comparator. This could be another drug on the market, or a...
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November 20, 2023
Guidelines Are Not Instruction Manuals: Customize Your Way to First-in-Human Clinical Trials
Interpreting all guidelines before your first-in-human clinical trials can be overwhelming. While guidelines are...
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November 13, 2023
First-in-Human Drug Substance and Formulation: The Challenge of Achieving Flexibility and Quality
For nonclinical studies that precede Phase I, a drug formulation in high doses and concentrations is required. While...
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January 30, 2019
Career Perspectives: Interview with Tina Checchio, Associate Director, Quantitative Pharmacology & Pharmacometrics
QPP remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it...
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January 10, 2019
Podcast: Overcoming Phase 1 Development Challenges
Nand Kishore Rawat is a Director and Head, Early Phase Biostatistics based in the King of Prussia, PA Cytel office. We...
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November 12, 2018
Can Statisticians Contribute to Enhance the Position of Patients in Clinical Trials?
In this blog, we talk with Robert Greene, Founder and President of the HungerNDThirst Foundation, about his upcoming...
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October 5, 2018
Interview with Stephen Senn: 70 Years and Still Here: The Randomized Clinical Trial and its Critics
We are delighted that Stephen Senn will be joining us at the EUGM on November 14th and 15th in Darmstadt, Germany. In...
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September 27, 2018
Decision Making in Development Programs with Targeted Therapies: with Heiko Götte
In this blog, we talk with Heiko Götte, Senior Expert Biostatistician at Merck about his upcoming presentation at...
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January 30, 2017
Accelerating development with combined SAD/MAD approach
Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies. They...
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