The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

Statistical Approaches to Overcome Challenges in Rare Disease Development

February 28, 2019


In honor of Rare Disease Day 2019 we share a new Cytel podcast featuring Cytel Strategic Consultant Ursula Garczarek discussing how innovative statistical approaches can overcome challenges in rare disease development. Below, you can access the podcast and a summary of some of Ursula's key insights from working in rare diseases and interacting with regulatory agencies for complex and innovative designs.

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Trends in Data Science: Podcast with Ursula Garczarek on The Effective Statistician

February 21, 2019

In 2018, Cytel ran a qualitative survey among biostatisticians and programmers on trends in data science and perceptions about the goals, barriers and future of the field in the biopharma and life science industry.  Our analysis and report revealed a range of insights from the respondents including :

Lack of shared understanding of what data science represents with less than 1 in 7 of all respondents suggesting a definition of data science.
Clear trend of investment in data science across organizational types with three-quarters of all respondents saying their organizations had a dedicated data science department.

An opportunity for improved clinical trial design by using data science techniques was recognized by the majority of respondents. In addition, respondents across all functions perceive the key opportunity for data science to be in maximizing the value of real-world data. 


In a recently published discussion on The Effective Statistician podcast ( a weekly podcast produced in association with PSI)  Ursula Garczarek, Associate Director Strategic Consulting at Cytel sat down with hosts Alexander Schacht and Benjamin Piske to discuss where the biopharma and life science industries are headed with the application of data science.

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Career Perspectives: Interview with Tina Checchio, Associate Director, Quantitative Pharmacology & Pharmacometrics

January 30, 2019

QPP remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it refers to several types of quantitative modeling including meta-analysis, PK/PD, statistical modeling and the modeling of go-no-go decision rules. Cytel’s expert Quantitative Pharmacology and Pharmacometrics group delivers high quality solutions to help our customers get those decisions right.

In this blog we talk to Tina who lives in Stonington, Connecticut, to find out more about her career path, current role at Cytel, and her interests outside of work.

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Infographic: 5 Key Interactions of Data Management and Statistics

July 27, 2018

In this blog, we share a new infographic based on this popular blog post illustrating some of the critical interactions that need to take place between data management and statistics groups to help ensure efficiency and data quality. 

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The Importance of Standardization in Clinical Outsourcing

June 19, 2018

 

At the recent PCMG conference in Malta, Adrian Otte ( Independent Consultant, formerly VP Global Development Operations at Amgen) presented to delegates the strategic choices open to sponsors when  choosing an outsourcing model and the three fundamental issues in play: standardization, flexibility and cost. In Dr. Otte's view, standardization of systems and processes is key, but is often overlooked as a factor by companies of all sizes when deciding how to outsource clinical trial activities. In this blog, Dr Otte joins us to share his insights on this topic, as well as this views on how outsourcing has evolved in recent years, and the future trends that will have most impact. 

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Infographic: Overcoming Data Management Challenges in Immuno-Oncology Trials

April 25, 2018

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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What makes a Successful FSP Partnership Tick?

March 14, 2018

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

November 22, 2017

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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Creating Efficiencies in the Vendor Qualification Process: A Proposal

November 15, 2017

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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