Highlights from the SCDM 2018 Conference

Posted by Cytel

Oct 16, 2018 11:00:00 AM

The Society for Clinical Data Management (SCDM) conference brought clinical data managers from around the world to Seattle-Bellevue, WA on September 23-26. The conference offered an unmatched opportunity to discover innovative solutions in the clinical data management industry. In this blog, we will share our data management colleagues' experiences, observed trends and contributions to the...

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Topics: clinical data management, data manager, Clinical Data, clinical research, clinical trials, clinical development, CDM


Maximizing Preclinical Knowledge for Optimal R&D

Posted by Cytel

Apr 3, 2018 2:00:00 PM

 

By Esha Senchaudhuri

In response to its R&D productivity from 2005 – 2010, AstraZeneca took the initiative in 2011 to implement what it has called the 5R Framework to strengthen its capabilities. In a Perspectives article from Nature Reviews Drug Discovery [1], Paul Morgan and his team provided complex details about the success of this framework from the perspective of every stage of drug...

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Topics: Program and Portfolio Optimization, quantitative decision-making, clinical development


Career Perspectives: Interview with Benjamin Esterni, Principal Biostatistician

Posted by Cytel

Mar 16, 2018 7:00:00 AM

At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking portfolios, accelerating timelines, and increasing the probability of success.

In this blog we talk to Benjamin who lives in France, to find out more about his career path, achievements, current role at Cytel and his interests outside of work. 

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Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, clinical development, clinical trials, adaptive trials, adaptive designs


Innovative posters unveiled at ACoP8

Posted by Cytel

Nov 2, 2017 9:05:00 AM

 

Last month was the eighth American Conference on Pharmacometrics (ACoP8) in Florida, a key event on the calendar for Cytel’s Quantitative Pharmacology and Pharmacometrics subject matter experts.

Cytel was delighted to contribute to the event this year and present two posters. This was excellent opportunity to share our knowledge and innovative research, alongside networking with likeminded...

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Topics: Clinical Data, pharmacometrics, pharmacology, Clinical Research Services, model-informed-drug-development, clinical development, Phase 1


Webinar Replay: Dual Target Methods for Go/No-Go Decision Making

Posted by Cytel

Oct 31, 2017 10:42:00 AM

As part of Cytel's new Trial Innovations Webinar Series, Pat Mitchell, Statistical Science Director at AstraZeneca presented the October webinar "Formal Go/No-Go decisions are a key component of risk management in early clinical development."

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Bayesian, adaptive designs, clinical development, go-no-go, custom software


Estimands 101: Interview with Mouna Akacha

Posted by Cytel

Feb 27, 2017 7:39:00 AM

 

It’s been hard to miss the prevalence of estimand-related discussions in the last year.  This is a topic which is very much at the forefront of statistics discussions right now.  We are lucky enough to welcome Mouna Akacha to the blog to give us the lowdown on estimands and the problems and opportunities they represent for the global biopharma industry. 

Mouna is a Consultant in the...

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Topics: biostatistics, clinical development, Regulation


R Beyond Statistics

Posted by Cytel

Oct 25, 2016 7:59:00 AM

 

Use of R is a hot topic among statisticians and programmers in the pharmaceutical industry.  At the recent PhUSE conference in Barcelona there was a clear uplift in interest in the  language and a number of sessions explored introductory principles and examples of how R can be used in practice.  Cytel's Namrata Deshpande presented on the use of R beyond Statistics through a case study of the...

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Topics: Statistical Programming, Clinical Research Services, clinical development, R, Rstats


The evolving role of the modern statistical programmer

Posted by Cytel

Oct 13, 2016 9:16:00 AM

Statistical programmers play a key role in turning the data from clinical trials into knowledge and supporting the development of new medicines.  In a dynamic industry with demands such as CDISC compliance, data transparency initiatives, big data, and cost pressures the role is evolving to become ever more multi-dimensional. Statistical programmers now have the opportunity to follow their...

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Topics: Statistical Programming, SAS, Clinical Research Services, clinical development


An efficient tool for model based meta-analysis

Posted by Cytel

Sep 20, 2016 9:42:00 AM

 

Drug development is an expensive and risky business.  To maximize a compound’s ultimate chances of commercial as well as regulatory success it’s imperative that sponsors are building up a strong understanding of its characteristics relative to competitors.  This knowledge can support critical decisions along the development path, such as optimizing dosing, and selecting the best active...

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Topics: pharmacology, pharmacometrics, clinical development, Clinical Development Strategy


Determining the future course of your trial

Posted by Cytel

Jun 16, 2016 10:23:00 AM

 Predicting the course of a clinical trial is something which people will always want to do-whether for statistical reasons, planning reasons or business reasons. In this blog we look at examples of where prediction goes off course, and how we can resolve these issues.  We also share valuable video and slidedeck resources from our VP Consulting and Software, Yannis Jemiai.

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Topics: East, East PREDICT, Interim Analyses, Cytel Videos, Cytel Events, clinical development, EAST 6.4, adaptive designs, adaptive trials, DMC


How can the CMO/Biostatistician connection improve clinical development?

Posted by Cytel

Jun 7, 2016 8:00:00 AM

 At the recent CMO Summit East  James ( Jim) Bolognese, Cytel’s Senior Director of Strategic Consulting, and Lou Vaickus,MD, FACP, Founder and President of aktaPD jointly explored how the critical connection between a CMO and a biostatistician can help enhance communication with internal and external stakeholders, ensure patient safety and ultimately improve clinical development efficiency....

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Topics: Clinical Development Strategy, go-no-go, clinical development, biostatistics, p value


Subgroup Analyses in Early Phase Clinical Trials

Posted by Cytel

May 10, 2016 8:00:00 AM

 

We were fortunate to welcome Björn Bornkamp of Novartis to the EUGM 2016 presenting work he has developed jointly with Marius Thomas (1) on methods of adjusting treatment effect estimates in subgroup analyses with a focus on early phase trials.   

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Topics: Early Phase Trials, clinical development, biostatistics, subgroup analysis


What's the price of pharma innovation?

Posted by Cytel

Apr 5, 2016 4:00:00 PM

 

 

Cost of pharmaceutical development and R&D productivity is an ongoing industry concern, consistently discussed in the mainstream and specialist press.  The issue is held in delicate balance against the increasing pressure on pharmaceutical pricing and cost containment measures.

A study by Tufts Center for the Study of Drug Development published earlier this year in the Journal of Health...

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Topics: Phase 1, Program and Portfolio Optimization, Phase 3, phase 2, go-no-go, clinical development


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