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 discuss
his work, his views on the key advancements in oncology development, the unmet needs yet to be overcome, and the importance of efficient trial design in rare cancers. Click here to download a .pdf of the article, or read on. 

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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 in software and services for managing CDISC compliance and clinical data quality.  The organization continues to offer a community based software tool, in line with the OpenCDISC model, but now offers an enterprise version to sponsors and CROs, that is also used by the FDA itself. 

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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 yet to be overcome, and the importance of strategic biostatistics input to his organization. Read on, or click here to download a copy of the article to read offline.

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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 sit down with Lucy Rowell, Senior Principal Statistical Scientist at Roche and the Conference Chair, to learn more about this year’s venue, themes, and new hot topics, along with insights on Lucy’s vision for the future of the PSI organization. We look forward to seeing you in The Netherlands! 


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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 of work.

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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 needed to overcome them. 

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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 programmers need to focus on to keep abreast of the evolving drug development landscape. 

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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 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


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 development. Between 2005 and 2010, AstraZeneca was behind industry averages in every phase of clinical development except Phase 1.  After the implementation of 5R, AstraZeneca success rates improved substantially. Indeed, it was announced by IDEA Pharma in March 2018 that AstraZeneca had topped its 2018 innovation index.  Here we examine to what Morgan et al, attribute AstraZeneca’s  success.  

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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 able to share our findings- read on for some highlights, and to download your complimentary copy of the report.

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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 management, pharmacovigilance, scientific medical writing, key therapeutic areas and crucial soft skills. With learning programs led by experienced trainers, CliPLab engages both with individual students, and companies (e.g. biopharma, CROs) needing to support and augment their internal training programs.

In this blog we share a case study of how CliPLab supported a pharmaceutical customer with a tailored SAS training program for a cohort of new graduate recruits. 

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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


What makes a Successful FSP Partnership Tick?

Posted by Natalie Fforde

Mar 14, 2018 11:31:00 AM

Photo by Agê Barros on Unsplash

by Natalie Fforde, Senior Director of FSP Services at Cytel


With effective use of outsourcing, sponsors are able to respond to market needs and change course where necessary, while ensuring a pool of highly qualified personnel are available to work on clinical trial projects. At Cytel we work with our clients to tailor the outsourcing model that works best for an organization's particular circumstances.
In this blog, I will take a look the Functional Service Provider ( FSP) outsourcing model and some of the key factors that can help make a partnership ‘tick’ successfully.

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Topics: Clinical Research Services, Statistical Programming, clinical data management


Creating an R-Package Template: A Guide

Posted by Ivan Navarro

Mar 8, 2018 6:05:00 AM

 

Photo by Steinar Engeland on Unsplash

By Ivan Navarro, Data Scientist at Cytel

R is an open-source implementation of ‘S’, the statistical programming language. With its open character and ability to extend its functionality using external packages, R allows users to create their own packages that are easily loadable into the core instance.
In essence, R-packages are extensions that contain source-code, documentation, data and examples of personal contributions and can be extremely useful for data scientists, statisticians and programmers alike who need to create custom analysis and visualizations. However, creating your first R-package can be a complex task for non-experienced users.
In this blog, I explain how to create a basic R-package which can be used as template for anyone interested in making a contribution. A previous knowledge on R programming is required, but you will not need to deal with technical aspects of the creation process because the R-Package structure is shared at the end.

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Topics: R programming, data science, R language


Best Sample Size Calculators for iPhone

Posted by Charles Liu

Mar 6, 2018 12:05:25 PM


Photo by Dose Media on Unsplash

By Charles Liu, Senior Product Manager, Cytel

Several years ago, I was one of few Luddites in my social circle still using a “dumb” phone. Other than calls, and (text only!) messaging, it had no other functionality. Once I made the switch, a whole new magical world unveiled itself. With the tap of a button, I could read my email, listen to a podcast, find a nearby restaurant, order a cab, snap a photo, and so on. What was once considered science fiction seems an indispensable part of life today.

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Topics: Sample Size, Trial Design Software, EAST 6.4


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, Senior Research Associate at CoRDS to learn more about the registry and hopes for the future.

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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


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