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...
Oct 16, 2018 11:00:00 AM
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 , Paul Morgan and his team provided complex details about the success of this framework from the perspective of every stage of drug...
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.
Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, clinical development, clinical trials, adaptive trials, adaptive designs
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...
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."
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...
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...
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...
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...
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.
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....
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.
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...