
Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.

September 22, 2020
Research Scientists, Thomas Wilke and Sabrina Mueller recently published a manuscript on “Diabetes-Related...
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April 2, 2020
Remote Working Arrangement – How to get it right?
On March 16, the World Health Organization (WHO) Director-General, Dr. Tedros Adhanom Ghebreyesus, in his media...
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February 28, 2019
Statistical Approaches to Overcome Challenges in Rare Disease Development
In honor of Rare Disease Day 2019 we share a new Cytel podcast featuring Cytel Strategic Consultant Ursula Garczarek...
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February 21, 2019
Podcast with Ursula Garczarek on The Effective Statistician
In 2018, Cytel ran a qualitative survey among biostatisticians and programmers on trends in data science and...
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January 30, 2019
Career Perspectives: Interview with Tina Checchio, Associate Director, Quantitative Pharmacology & Pharmacometrics
QPP remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it...
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July 27, 2018
Infographic: 5 Key Interactions of Data Management and Statistics
In this blog, we share a new infographic based on this popular blog post illustrating some of the critical interactions...
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June 19, 2018
The Importance of Standardization in Clinical Outsourcing
At the recent PCMG conference in Malta, Adrian Otte ( Independent Consultant, formerly VP Global Development Operations...
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April 25, 2018
Overcoming Data Management Challenges in Immuno-Oncology Trials
Data management is an essential building block for successful Immuno-Oncology (I-O) trials. At the Immuno-Oncology...
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March 14, 2018
What makes a Successful FSP Partnership Tick?
Photo by Agê Barros on Unsplash by Natalie Fforde, Senior Director of FSP Services at Cytel With effective use of...
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November 22, 2017
Career Perspectives: Interview with Makarand Deshmukh, Senior Clinical Data Analyst
Cytel offers a full range of clinical data management services and the team of experts is spread across the globe. In...
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November 15, 2017
Creating Efficiencies in the Vendor Qualification Process: A Proposal
Each year Halloran Consulting Group hosts‘CORE’ (Clinical Operations Retreat for Executives) as a forum for industry...
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September 29, 2017
Career Perspectives: Interview with Namrata Deshpande, Senior Team Lead
Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event...
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September 13, 2017
How can Novel Statistical Methods Tackle Antibiotic Resistance?
Antibiotic resistance is one of the greatest challenges facing human health today. We are excited to welcome Dr. Scott...
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September 11, 2017
Design Concept for Basket Trials: Interview with Bob Beckman
At the East User Group meeting (EUGM) on 25th and 26th October, we will welcome a number of renowned industry speakers...
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August 2, 2017
Case Study: Cross-study Efficiencies in Biometrics Outsourcing
As a biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and...
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July 19, 2017
Case Study: Seamless Independent Data Monitoring Committee Support
With adaptive and innovative trial designs on the rise, operational implementation of interim analyses, including...
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July 13, 2017
Creating Data Visualizations with R and Shiny
By Tejasweeni Rajput It’s been known for centuries that a picture can tell a thousand words. In an era of new...
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June 28, 2017
Under wraps: the importance of patient privacy
About the Author: Manjusha Gode has over 28 years' IT experience spanning delivery Management, quality management,...
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March 20, 2017
The Role of the Independent Randomization Center
In the randomized clinical trial (RCT), the process of deciding the randomization method and implementing is critically...
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March 15, 2017
The Data Management Plan Takes Center Stage- why is it so important?
A precise and thorough approach to planning is key for success in data management. The Data Management Plan (DMP) is a...
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November 21, 2016
Infographic: 10 steps to consider before choosing an adaptive design
While adaptive designs can deliver significant benefits to clinical development- including ethical benefits for...
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October 25, 2016
R Beyond Statistics
Use of R is a hot topic among statisticians and programmers in the pharmaceutical industry. At the recent PhUSE...
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October 13, 2016
The evolving role of the modern statistical programmer
Statistical programmers play a key role in turning the data from clinical trials into knowledge and supporting the...
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October 5, 2016
Challenges in Neuroscience Clinical Trials
While some progress has been made in terms of scientific development in Neuroscience and Neuropsychiatry indications,...
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September 9, 2016
Case Study:Seamless Phase 2/3 Design in Rare Disease
Challenge: Our client, an emerging biotechnology company, was preparing for the next stage of development for their...
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September 7, 2016
Overcoming challenges of 'Less Well Understood' Adaptive Designs
In the 2010 draft FDA ‘Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics', the agency...
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August 9, 2016
Operational and regulatory considerations in a promising zone trial
At the recent JSM Meeting, Cytel’s Yannis Jemiai presented the case study of the VALOR trial which used a promising...
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August 2, 2016
The CRO role in Data Standards Governance
Editor's note( this blog was refreshed in April 2018) As CDISC compliant submissions become increasingly expected,...
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July 28, 2016
6 steps to timely database lock
To close a clinical database right the first time you have to begin with study start-up. Clearly, you can’t close a...
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July 12, 2016
Key considerations in selecting an EDC system
How do you go about selecting the best Electronic Data Capture (EDC) system for your study? There is now a vast amount...
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June 23, 2016
Getting the best out of your biometrics RFP
Vendor selection is a critical component of ensuring clinical trial success. A 2015 report (1) suggested that clinical...
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June 14, 2016
Managing DMC analysis- an innovative programming solution
At Cytel, we are very often asked to get involved in DMCs ( Data Monitoring Committees) in a variety of capacities. Our...
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May 12, 2016
Lost in Traceability- From SDTM to ADaM
Once upon a time Hansel and Gretel laid a trail of breadcrumbs which they followed to find their way back home. Their...
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April 26, 2016
Overcoming Data Management Challenges in Oncology Studies
In this blog we’ll highlight some unique challenges that are encountered from a Data Management perspective when...
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April 20, 2016
Handling CDM data integrations
During the course of any clinical trial, there are often data which, while collected electronically, are outside of the...
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April 15, 2016
5 Key Interactions of Clinical DM and Statistics
It's critical for biostatistics and data management to be closely aligned and working effectively together. The...
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February 26, 2016
Getting Technical: The evolving role of the Data Manager
Remember the early days of Electronic Data Capture? Those first systems, which were revolutionary for their time...
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November 5, 2015
The 24 Hour Work Day
Oftentimes people perceive a tradeoff between speed and quality. The faster you do something the more likely you are to...
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August 13, 2015
Do you really need a full service CRO? An exploration of strategic options
Full service or specialized? Full service or specialized? For many looking to hire a CRO, the answer is obvious....
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June 5, 2015
Building Teams to Handle Unexpected Regulatory Agency Requests
Not long ago, one of our clients submitted Phase 2 and Phase 3 data for a new rare disease drug which had received...
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May 28, 2015
How to Use Outsourcing to Reduce Clinical Development Risk
Risks in drug development range from taking the wrong drugs forward to Phase 3 to investing in a drug development...
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April 21, 2015
Adaptive SSR for Small Sample Sizes?
“We shouldn’t use an adaptive design, our sample size is too small.” Most clinical trial planners have heard this line...
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December 2, 2014
How to Incorporate New Technology into Your Clinical Development Strategy
During a recent DIA webinar on reinventing the clinical trial, Laurie Halloran (President of the Halloran Consulting...
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October 7, 2014
You Own This!
Guest blogger Laurie Halloran is the President and CEO of Halloran Consulting Group, a management consulting firm for...
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July 24, 2014
Data Management and Biostatistics III: Statistical Innovation in Clinical Data Management
This is the third post in a three part series in which we consider (i) improvements to trial quality that result from...
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June 3, 2014
Data Management & Biostatistics II: Operational Benefits of Bundling
This is the second post in a three part series in which we consider (i) improvements to trial quality that result from...
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May 22, 2014
Data Management & Biostatistics I: Improving Trial Quality
This is the first of a three part post in which we will consider (i) improvements to trial quality that result from...
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