Interview with Ken Getz: Exploring Challenges of Clinical Trial Operations Part 2

Posted by Cytel

Apr 13, 2018 7:21:00 AM

We return to our discussion with Ken Getz of the Tufts CSDD for part 2 of our blog post on  key challenges in clinical trial operations. You can find Part 1 of the interview here, or read on to gain his insights on the fundamental problem at the heart of clinical trial operations challenges, and his views on the initiatives and programs that he believes show the most promise for the future. 

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Topics: forecasting, patient enrollment, enforesys, clinical trials


Interview with Ken Getz: Exploring Challenges of Clinical Trial Operations Part 1

Posted by Cytel

Apr 5, 2018 8:30:00 AM

Photo by J. Kelly Brito on Unsplash

Research on clinical trial enrollment makes for sobering reading, characterized by the oft-cited statistic that 11% of active sites fail to enroll a single patient. In this first part of a two part interview, we sit down for a discussion with Ken Getz of the Tufts CSDD. Here, Mr. Getz expands on some of the Center’s more recent research on challenges in clinical trial operations. In the second part, to be published  next week, Mr. Getz will reveal his insights on the key opportunities for the future. 

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Topics: forecasting, patient enrollment, enforesys, clinical trials


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


Developing efficient tools for ADaM dataset creation

Posted by Diganta Bose

Feb 21, 2018 10:00:00 AM

 

By Diganta Bose, Statistical Programming Team Lead at Cytel

Editor's note: This blog is based on work presented at ConSPIC 2017

Innovation within CROs is critical to enhance efficiency, reduce costs, and increase productivity. Importantly, process innovation can also help limit errors, and reduce efforts required by a team to conduct a specific task, so freeing them up for other value-adding activities. The process and technology innovations developed by statistical programmers can make important contributions to improved productivity and aid the industry-wide drive to accelerate new products to market.

In a previous blog, we highlighted an innovative solution developed by Cytel’s Angelo Tinazzi and Dean Shultsto improve efficiency in the Data Monitoring DMC programming process. In this article, I will provide an overview of another programming innovation project, which aims to improve the efficiency of creating ADaM datasets.

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Topics: Statistical Programming, Statistical Analysis, clinical trials


Career Perspectives: Interview with Ursula Garczarek, Associate Director - Strategic Consulting

Posted by Cytel

Feb 13, 2018 9:00:00 AM

Our strategic consulting team work on projects such as: Identifying the best clinical trial design, implementing adaptive designs, developing a regulatory strategy and interacting with regulators.

In this blog we talk to Ursula who is based in Germany, to find out more about her career path, achievements, current role at Cytel and her interests outside of work. 

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


Life in Programming: Interview With Ajay Sathe

Posted by Cytel

Feb 6, 2018 4:34:00 AM

 We were excited to learn recently that Ajay Sathe, the CEO of our India Operations, was awarded lifetime honorary membership of PhUSE in recognition of his contributions to the influential statistical programming organization. Ajay is a well-known figure in the global statistical programming community and in this blog we chat with him about his work, the important role of PhUSE in the industry, and what excites him most about work in the biopharma sector.

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Topics: Statistical Programming, Statistical Analysis, clinical trials, CRO, PhUSE


Highlights from PhUSE 2017

Posted by Cytel

Nov 17, 2017 5:00:00 AM

PhUSE 2017 took place in Scotland’s capital city Edinburgh, 8th - 11th October, and brought together a range of experts to tackle the most pressing issues facing statistical programmers today.  We found this year's event informative and well attended. In this blog we share some highlights from the sessions and posters the Cytel team attended.  We will share Cytel's own contributions in a separate article.

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Topics: Statistical Programming, FDA, Interim Analyses, biostatistics, CDISC, R programming, clinical trials


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