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

September 1, 2023
Data is the cornerstone of any clinical trial, driving the decision-making process of drug development, and is a...
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June 9, 2023
Maximizing Study Momentum: A Case Study in Accelerated DMC Safety Report Creation through IDMC Solutions
In the ever-evolving landscape of clinical development, the need for robust evaluation of interim clinical data through...
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March 30, 2021
The Integration Dilemma
As of today, our Industry has not defined any approach, nor does an official regulatory agency...
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March 11, 2021
Data and analysis in Modern Oncology Clinical Development
In the recent years, Oncology trials are seeing a technological shift that is expected to make them faster and more...
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February 24, 2021
Avoiding Lost-in-Translation with Submission Terminology
In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM....
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January 28, 2021
A little walk in the CDISC Library, hand in hand with SAS
The Christmas break presented an opportunity to make my first concrete steps into the CDISC Library. Overall, it was a...
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December 18, 2020
Submitting Software Programs to the Regulatory Agencies
Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit...
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November 23, 2020
Data Standards and Submission Highlights from PHUSE EU CONNECT 2020
The Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all...
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November 19, 2020
10 Key Qualifications for Independent Statisticians Reporting to the DMC
Data Monitoring Committees (DMCs) are groups of independent experts who periodically receive (by-arm) reports created...
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November 3, 2020
Staffing Needs for RWE Delivery
When an expert statistician is paired with an experienced set of data managers, opportunities to capitalize on...
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October 28, 2020
When your ADaM package is not traceable back to SDTM
About three years ago, Cytel was helping a sponsor on a project where I had to conduct surveillance of some CRO...
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July 7, 2020
Overcoming Clinical Development Challenges in Oncology with Innovative
Having its roots in the seminar rooms of the Dana Farber Cancer Institute, Cytel has a long record of establishing new...
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June 9, 2020
Melinda Gates, on COVID-19 and Drug Development in Emerging Economies
Trevor Mundel leads the Bill & Melinda Gates Foundation’s efforts to develop high-impact interventions against the...
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March 5, 2020
Managing risk in clinical development: Is your data strategy fail-safe?
Generating high-quality clinical data is a vital but challenging task in modern drug development. Unfortunately, in the...
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February 20, 2020
Unlock the power of your clinical data with these five top tips
It is widely acknowledged among drug developers that one of their most important assets is the data generated during...
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February 6, 2020
Is your data strategy set up to tackle key challenges in early clinical development?
In clinical development, a high-quality evidence package is a prerequisite for a new therapy to gain approval from...
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January 22, 2020
What could you accomplish with a fresh approach to your clinical data strategy?
In the quest for clinical success, we all strive for evidence packages of the highest quality. If the clinical data is...
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April 24, 2019
Assuring Outsourcing Obligations with Specialist Data Management Oversight
In this blog, Alla Muchnik, Senior Clinical Data Manager at Cytel, discusses how specialist CROs can add value 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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November 8, 2018
Data Management Fundamentals for Your Next Clinical Trial
Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process...
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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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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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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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May 4, 2017
The Data Management Perspective on the Interim Analysis
As a recognized expert in adaptive trials, Cytel has extensive experience designing and managing trials with interim...
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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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October 7, 2016
Adaptive Designs: A Data Management Perspective
Adaptive designs have the potential to accelerate clinical development, and improve the probability of trial success....
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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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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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December 1, 2015
Making the Most of Data Management for Risk Based Monitoring
Risk based monitoring is a strategic monitoring practice which aims to shine the spotlight on problematic study areas,...
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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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October 19, 2015
3 Statistical Challenges for Pooling Phase 1 Data
It is often necessary to pool safety data from late phase studies, in preparation for regulatory submission. Some of...
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September 24, 2015
Virtual Teams and Clinical Data Management
Earlier this week, Patti Arsenault, Cytel’s Global Head of Clinical Data Management, sat on an SCDM panel with members...
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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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May 15, 2015
Can You Reproduce Your Clinical Trial Results?
Imagine that it’s been three years since the completion of a trial, and that suddenly a regulatory body calls into...
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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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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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