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


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


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 looks. This extends the methodology to provide for multiple (K>2) looks. The methodology is applied to the data from the RALES study (Pitt et al., 1999; Wittes et al., 2001).

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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


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


6 Innovative Trial Design Videos

Posted by Cytel

Jan 26, 2018 9:03:00 AM

The  Cytel YouTube Channel hosts a wealth of video presentations from Cytel experts as well as external industry and academic speakers about various aspects of clinical trial designs and their implementation.  In this blog, we've gathered 6 popular resources from the channel on topics from quantitative decision-making through to overcoming challenges in management of oncology trials. Read on to learn more and access the videos. 

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Topics: East PREDICT, Cytel Videos, Adaptive Clinical Trials, Multi-Arm Studies, pharmacometrics, Multi-Arm Multi-Stage Studies, biostatistics, EAST 6.4, adaptive designs, model-informed-drug-development


Interview: Promoting precision medicine using data science 

Posted by Cytel

Jan 23, 2018 10:36:00 AM

 News Medical interviewed Dr. Rajat Mukherjee, Statistician, and Director of Data Science at Cytel to investigate the potential of data science in clinical development.

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Topics: Precision Medicine, Simulation & Biomarkers, big data, data science, biomedical signals


Addressing the Problem of Feature Selection Using Genetic Algorithms

Posted by Munshi Imran Hossain

Jan 15, 2018 8:12:00 AM

The problem of feature selection

The explosion in the availability of big data has made complex prediction models a conspicuous reality of our times. Whether in banking, financial services and insurance, telecoms, manufacturing or healthcare, predictive models are increasingly used to derive inference from data.

Most of these models use a set of input variables, called features, to predict the output on a variable of interest. For example, the concentration of characteristic biomarkers in the blood can be used to predict the presence, absence or progress of certain diseases.

The available data can provide a large number of features, but generally, it’s preferable to use a small number of really relevant features in a model. This is because a model with more features has a greater complexity which leads to greater demand on computational resources and time to train the model. Therefore it is desirable to restrict the number of features in a predictive model. Choosing the subset of features that will result in a model with optimum performance is the problem of feature selection. This is essentially a problem of plenty.

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Topics: big data, data science, genetic algorithm


Career Perspectives: Interview with Lisa Goldberg, Associate Director of Statistical Programming

Posted by Cytel

Jan 9, 2018 8:13:57 AM

Our Career Perspectives' series is back! 

Cytel has industry-leading experts in statistical programming with years of SAS® Programming expertise, combined with in-depth knowledge of specific clinical subject matter, which allows for competent and on-time completion of tasks. Our extensive service offering includes CDISC migration, mapping to SDTM and statistical programming.

In the first blog of 2018, we talk to Lisa, who is based in Boston, to find out more on her career path, achievements, current role at Cytel and her interests outside of work.

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Topics: Recruitment, Statistical Programming, Statistical Analysis, CDISC, SAS, careers, CRO, clinical research


How Can We Tackle Heterogeneity in Meta-Analysis?

Posted by Anwaya Nirphirake

Jan 3, 2018 11:10:00 AM

Health professionals and policy makers want to make healthcare decisions based on the relevant research evidence. The questions in clinical research are typically studied more than once independently by different researchers. Literature review is used for summarizing the results of these studies and strengthening the evidence. Systematic review is a type of literature review that collects and critically analyzes multiple research studies or papers that answer the same question. If the results of these multiple studies are diverse and conflicting then the clinical decision-making becomes difficult. To overcome this problem meta-analysis is used. Meta-analysis is a statistical procedure for combining the results of studies that are included in systematic review. While meta-analysis is a powerful technique, it may give misleading results due to issues like improper selection of studies, publication bias, and heterogeneity among studies. In this blog, we will focus on the problem of heterogeneity.

 

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Topics: custom software, meta-analysis


Round-Up:The 6 Hottest Blog Topics from 2017

Posted by Cytel

Dec 21, 2017 6:44:00 AM

As we prepare to close the door on 2017, we thought we would take a look back at the  topics which have been most popular on the Cytel blog this year.  It's an interesting insight on what pain points and opportunities feature highly on our global biopharma audience's radar.  Read on to learn which of our 2017 blogs have received the most interest from our audience so far.

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Topics: Oncology, Data Management, Cytel Strategic Consulting, Statistical Analysis, Trial Design Software, pharmacometrics, estimands, NONMEM, data science, R language


Providing Evidence that Pollution Accelerates Skin Aging in Fast Moving Consumer Goods Trial

Posted by Cytel

Dec 19, 2017 6:11:00 AM

 

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Topics: Trial Design, Statistical Analysis, FMCG


Signal Management Using R

Posted by Krishna Asvalayan

Dec 12, 2017 7:33:00 AM


Signal management is one of the most audited pharmacovigilance processes. It also generates one of the highest findings from audits. The ability of Marketing Authorisation Holders (MAHs) to make a robust signal management system that is fully audit/inspection ready sometimes falls short of expectations. Happily, technology can be used to make the process more scientific and rigorous.
Technology in the signal management process can be divided into two categories. The first one is the front end i.e. what platform (.Net/JAVA) is being used to develop the system. The second is the back end i.e. what programs/software (R, Python, SAS) are used to process the data. In this blog, we will focus on the second category and discuss how R specifically can help improve the signal management process.

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Topics: Statistical Analysis, data science, pharmacovigilance, R language, signal detection


Slides: East User Group Meeting and Trial Design Symposium

Posted by Cytel

Dec 4, 2017 11:28:00 AM


In 2011, Cytel organized its first East User Group Meeting (EUGM) in Paris. Since then, we have held an EUGM almost every year, alternating between locations in Europe and North America.  These meetings have been a great success, giving opportunities for customers and industry colleagues to meet each other as well as with key opinion leaders, whilst learning more about our East software and providing critical feedback. 

This year, the EUGM was held in Cambridge MA on the 25th and 26th of October. In this blog we are delighted to share the slides from some of the speakers' presentations. 

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Topics: Cytel Strategic Consulting, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, EAST 6.4, adaptive trials


Interview: Clinical Trial Optimization with R

Posted by Cytel

Nov 28, 2017 10:27:00 AM

 

In this blog we turn to some reading matter, and interview Gautier Paux and Alex Dmitrienko about the recent book 'Clinical Trial Optimization with R'.  The book explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. To learn more, read on for Paux and Dmitrienko's insights.

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Topics: Cytel Consulting, Clinical Development Strategy, Software Simulations


Career Perspectives: Interview with Makarand Deshmukh, Senior Clinical Data Analyst

Posted by Cytel

Nov 22, 2017 8:46:00 AM

Cytel offers a full range of clinical data management services and the team of experts is spread across the globe.

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

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Topics: Data Management, Clinical Research Services, Statistical Programming, Statistical Analysis, careers, clinical data management, clinical research


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


Creating Efficiencies in the Vendor Qualification Process: A Proposal

Posted by Cytel

Nov 15, 2017 8:46:00 AM

Each year Halloran Consulting Group hosts‘CORE’ (Clinical Operations Retreat for Executives) as a forum for industry executives to discuss pressing challenges in a collaborative environment. This year, our Senior V.P. of Clinical Research Services, Irving Dark, discussed the topic of vendor qualification and posed the question to the group: are there better alternatives to the traditional qualification audit process? In this blog, we present Irving’s proposal for an innovative approach that could improve efficiency and allow sponsors to invest more time evaluating the operational and cultural aspects that have greater potential to ensure the success of a partnership

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Topics: Clinical Research Services, outsourcing, Clinical Data, CRO


The Cytel Story: In the Co-Founders' Own Words

Posted by Cytel

Nov 9, 2017 11:43:00 AM

 In this blog we are excited to unveil a new project which we have been hard at work on over the last few months. 

2017 marks a very special milestone for Cytel – our 30th anniversary.  Cyrus Mehta and Nitin Patel founded Cytel in 1987 with an initial objective to solve a specific problem in computational statistics.

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Topics: Cytel Consulting, Clinical Development Strategy, biostatistics


Asking the Right Questions of Your Data: Experiences in Model Informed Drug Development

Posted by Cytel

Nov 6, 2017 5:28:43 AM

 At the Chief Medical Officer Summit earlier this year, Cytel's Director of Quantitative Pharmacology and Pharmacometrics Cecilia Fosser, and Senior Director, Business Development, Chuck Gelb presented on how model-informed drug development (MIDD) techniques can improve decision-making and Probability of Success ( PoS) of clinical trial programs.  In this blog, we share some highlights and the informative10-minute video replay of their talk which includes a modeling and simulation case study. 

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Topics: Clinical Development Strategy, pharmacometrics, biostatistics, model-informed-drug-development


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