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5 Reasons to Integrate Model-Based Meta-Analyses (MBMA) Into Your Clinical Development Strategy

Posted by Cytel

May 31, 2018 3:48:00 PM

By Esha Senchaudhuri

An important trend in clinical development involves integrating strategic pharmacometric analysis with program level decision-making, to make the most use of available data. This can occur in various forms, from leveraging preclinical data for go-no-go decision making [1], to the need for improved comparative effectiveness frameworks [2].

Here we have five reasons why you...

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Topics: pharmacometrics, biostatistics, pharmacology, meta-analysis, quantitative decision-making


Addressing Critical Unmet Oncology Needs in the Era of Precision Medicine

Posted by Cytel

May 23, 2018 12:21:00 PM

 

 

Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic indications and other critical areas of medical unmet need.

In this article, we sit down with Charles Theuer, M.D., CEO of TRACON Pharmaceuticals to discusshis work, his views on the key advancements in oncology development, the unmet needs yet to be overcome, and the importance of...

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Topics: Oncology, Phase 1, Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, biostatistics


Exploring Differences Between Pinnacle 21 Community and Enterprise versions for CDISC Compliance

Posted by Cytel

May 22, 2018 6:39:00 AM

 At the recent CDISC EU Interchange in Berlin,  Angelo Tinazzi, Director of Clinical Data Standards and Submissions at Cytel, showcased a popular poster presentation analyzing the differences between the Pinnacle 21 enterprise (P21e) and community versions. Those working in the field of data standards, will know that Pinnacle 21 is led by the team that created OpenCDISC, and is now the leader...

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Topics: Statistical Programming, CDISC


Rewriting the oncology textbook with cell-based immunotherapies

Posted by Cytel

May 16, 2018 11:00:00 AM

 

Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic indications and other critical areas of medical unmet need.

In this article, we are delighted to share an interview with Kurt Gunter, M.D., Chief Medical Officer of Cell Medica in which he discusses his work, his views on the key advancements in oncology development, the unmet needs...

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Topics: Oncology, Phase 1, Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, biostatistics


Innovative Oncology Trial Designs in Practice

Posted by Cytel

May 9, 2018 10:22:00 AM

As we prepare to head to ASCO in under a month's time, we are pleased to share a new ebook that showcases some key applications of innovative trial designs in the oncology development space.

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Topics: Oncology, Phase 1, Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, biostatistics


Breaking Boundaries in Drug Development at PSI

Posted by Cytel

May 2, 2018 5:07:00 AM

PSI is a global member organization dedicated to leading and promoting best practice and industry initiatives for statisticians in the biopharmaceutical industry. The PSI annual conference is going from strength to strength, attracting increasing numbers of delegates from Europe and beyond. With the 2018 conference taking place in Amsterdam in only a month’s time, we took the opportunity to...

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Topics: biostatistics, data science, quantitative decision-making


Career Perspectives: Interview with Omar Sefiani, Principal Statistical Programmer

Posted by Cytel

Apr 28, 2018 9:50:00 AM

Cytel has industry-leading experts in Statistical Programming, our programmers have years of SAS® Programming expertise, combined with in-depth knowledge of the specific clinical subject matter, which allows for competent and on-time completion of tasks.

In this blog, we talk to Omar, who is based in Geneva to find out more about his career path, current role at Cytel and his interests outside...

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Topics: Recruitment, Trial Design, Statistical Programming, Statistical Analysis, Phase 3, CDISC, careers, clinical trials, CRO, clinical research


Infographic: Overcoming Data Management Challenges in Immuno-Oncology Trials

Posted by Cytel

Apr 25, 2018 10:13:00 AM

Data management is an essential building block for successful Immuno-Oncology (I-O) trials. At the Immuno-Oncology Clinical Trials operations meeting in New York in earlier this year,  Patti Arsenault, VP Quality Assurance at Cytel discussed with Christopher Lamplugh, AVP, Clinical Data Management, Global Data Operations at Merck, the key challenges for data management in the space, and what’s...

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Topics: Oncology, Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, big data, clinical trials


Developing the Next Generation of Skills for Statistical Programmers

Posted by Cytel

Apr 18, 2018 6:09:00 AM

Our recent Clinical Biometrics Survey explored the views of respondents from across the statistical programming, biostatistics, and data management functions to learn their top challenges, and most important perceived industry trends and skills development. In this blog, our Ajay Sathe gives his perspectives on the key areas of personal and knowledge development that he believes statistical...

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Topics: Statistical Programming, biostatistics, SAS, clinical data management, R language


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...

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Topics: forecasting, patient enrollment, enforesys, clinical trials


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, clinical development, quantitative decision-making


Clinical Biometrics Survey Reveals Industry Challenges and Trends

Posted by Cytel

Mar 29, 2018 8:44:00 AM

 

To mark the occasion of our 30th anniversary, in late 2017 we conducted a brief survey to gain a snapshot of what professionals in data management, statistical programming, and biostatistics feel are the key challenges facing their functions, the top areas for skills development, and the clinical data areas they believe are likely to have the greatest impact on drug development.

We are now...

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Topics: Statistical Programming, biostatistics, SAS, Biometrics, clinical data management


A Year in the Life of a Software Trainer

Posted by Cytel

Mar 27, 2018 11:20:00 AM

 East is the industry standard platform for clinical trial design, simulation, and monitoring, improving scientific productivity during the critical planning stages of clinical development.  In this blog, our Hrishikesh Kulkarni takes us on a tour of his life as a Cytel software trainer and answers some frequently asked questions about how East training sessions work in practice.

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Topics: East ESCALATE, Trial Design Software, Multi-Arm Multi-Stage Studies, EAST 6.4


Case Study: CliPLab Develops and Implements a Clinical SAS Intensive Training

Posted by Cytel

Mar 20, 2018 8:06:00 AM

 

Photo by Nghia Le on Unsplash

CliPLab (Clinical Professional Laboratory) is Cytel’s premier training initiative for bridging the skills gap in biometrics and analytics within clinical development. Leveraging Cytel’s experience and reputation in biostatistics and clinical biometrics, the organization provides practical learning modules in clinical SAS programming, biostatistics, data...

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Topics: Statistical Programming, SAS


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


Interview: Insight into the Coordination of Rare Diseases at Sanford (CoRDS) registry 

Posted by Cytel

Feb 28, 2018 9:02:00 AM

There is a consensus in the industry that data on rare diseases is limited, incomplete, and difficult to find or access. Recently we came across the CoRDS patient registry based at Sanford University and learned that the registry is an effective tool used to gather information useful to researchers studying rare diseases.

We sat down with Benjamin Forred, Project Manager, and Austin Letcher,...

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Topics: Rare Disease, Clinical Data, Adaptive Clinical Trials, real world evidence, CRO, clinical research


Cytel Congratulates Lipopharma and CLINGLIO Consortium on Recent Grant Award

Posted by Cytel

Feb 27, 2018 4:38:00 AM

We extend our congratulations to Lipopharma and the CLINGLIO project consortium on their recent 6,15M€ grant award by the European Union’s Horizon 2020 program. Led by Lipopharma, the multinational consortium brings together 12 academic and industry organizations from Europe, Israel, and the USA.

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Topics: Oncology, Trial Design, adaptive trials, personalized medicine


Recent Publication: A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group Sequential Design with Multiple Interim Looks

Posted by Cytel

Feb 15, 2018 10:35:00 AM

A recent publication in Biometrics ‘A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group Sequential Design with Multiple Interim Looks’ greatly extends the results of Glimm et al. ( 2010) and Tamhane et al ( 2010) which studied the problem of testing a primary and secondary endpoint, subject to a gatekeeping constraint, using a group sequential design (GSD) with K = 2...

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Topics: Cyrus Mehta, Statistical Analysis, Group Sequential, biostatistics, adaptive 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


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