Case Study:Creating an Effective Functional Services Partnership

Posted by Cytel

Jul 16, 2018 2:49:00 AM

In this blog we share a case study of how we established and ramped up a functional service outsourcing partnership for biostatistics, programming and data management.

Read More

Topics: Statistical Programming, outsourcing, SAS


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. 

Read More

Topics: Statistical Programming, CDISC


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.

Read More

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


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. 

Read More

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


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.

Read More

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


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. 

Read More

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. 

Read More

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.

Read More

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


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.

Read More

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. 

Read More

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.

Read More

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


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.

Read More

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


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. 

Read More

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.

Read More

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


Career Perspectives: Interview with Namrata Deshpande, Senior Team Lead

Posted by Cytel

Sep 29, 2017 3:01:00 PM

Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event in California, October 19-21.

This is the first blog in a new 'Career Perspectives' series and we talk to Namrata to find out more on her career path, achievements, current role at Cytel and her interests outside of work. 

Read More

Topics: East, Clinical Research Services, Statistical Programming, Statistical Analysis, Clinical Development Strategy, Statistical Innovations in Clinical Development, biostatistics, R programming, careers


Case Study: Cross-study Efficiencies in Biometrics Outsourcing

Posted by Cytel

Aug 2, 2017 7:07:00 AM

As a  biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and helping to minimize the oversight burden for the sponsor. In this case study, we describe our work with a client on two Phase 1 studies, and how we were able to carry a number of important efficiencies from the first study to the second.  

Read More

Topics: Clinical Research Services, Statistical Programming, Phase 1, outsourcing, Clinical Data, biostatistics, clinical data management, medical writing


Don’t miss these 5 session picks at JSM

Posted by Cytel

Jul 25, 2017 7:37:09 AM

The Joint Statistical Meetings (JSM) is the largest and arguably most highly respected gathering of statisticians in the world.  It will bring together over 6000 statisticians and runs from Saturday, July 29, to Thursday, August 3, 2017. With over 600 sessions,  it can be a challenge to identify the most crucial ones to attend. To help out, we've asked some of the Cytel team for their top picks this year. 

Read More

Topics: Oncology, Clinical Research Services, Statistical Programming, Statistical Analysis, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, biostatistics


Case Study: Seamless Independent Data Monitoring Committee Support

Posted by Cytel

Jul 19, 2017 9:00:13 AM

With adaptive and innovative trial designs on the rise, operational implementation of interim analyses, including management of Independent Data Monitoring Committees is increasingly important.  In this blog, we will share a case study of how Cytel provided a client with seamless Independent Data Monitoring Committee support encompassing committee selection and management, independent statistical services, and ACES software. 

 

Read More

Topics: Clinical Research Services, Statistical Programming, Interim Analyses, ACES, biostatistics, DMC


Creating Data Visualizations with R and Shiny

Posted by Cytel

Jul 13, 2017 5:25:00 AM

By Tejasweeni Rajput

It’s been known for centuries that a picture can tell a thousand words. In an era of new technologies, and increasing volume of information, visualizations can help us to express complex data simply and effectively. Advanced technology is now available that allows statisticians and data scientists to drill down into the data sets to be analysed, and develop dynamic graphics that one can interact with. This marks a leap forward in decision-making capabilities from the static figures which have been traditionally available to us.

Read More

Topics: Clinical Research Services, Statistical Programming, biostatistics, R programming


Under wraps: the importance of patient privacy

Posted by Manjusha Gode

Jun 28, 2017 4:36:40 AM

About the Author: Manjusha Gode has over 28 years' IT experience spanning delivery Management, quality management, software testing,  people management, process improvement and multi-locational operations.  She is a pioneering member of Cytel's clinical programming team.

 Clinical data transparency improves decisions for all healthcare stakeholders including patients, caregivers, healthcare providers, payers, and regulators.

The topic of transparency and the process by which clinical trial data can be effectively anonymized and disclosed for use by researchers has become a hot topic in recent years. In this blog, we will discuss the broader context of patient privacy and the key considerations for biopharmaceutical companies in this area.

Read More

Topics: Clinical Research Services, Regulation, Statistical Programming, biostatistics, CDISC


The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.  Sign up for updates direct to your inbox. You can unsubscribe at any time.

 

Posts by Topic

see all

Recent Posts