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
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
As of today, our Industry has not defined any approach, nor does an official regulatory agency...
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March 11, 2021
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
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
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
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
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
Data Monitoring Committees (DMCs) are groups of independent experts who periodically receive (by-arm) reports created...
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November 3, 2020
When an expert statistician is paired with an experienced set of data managers, opportunities to capitalize on...
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October 28, 2020
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
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
Trevor Mundel leads the Bill & Melinda Gates Foundation’s efforts to develop high-impact interventions against the...
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March 5, 2020
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
It is widely acknowledged among drug developers that one of their most important assets is the data generated during...
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January 22, 2020
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
In this blog, Alla Muchnik, Senior Clinical Data Manager at Cytel, discusses how specialist CROs can add value and...
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November 8, 2018
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
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
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
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
As a recognized expert in adaptive trials, Cytel has extensive experience designing and managing trials with interim...
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March 15, 2017
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 have the potential to accelerate clinical development, and improve the probability of trial success....
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August 2, 2016
Editor's note( this blog was refreshed in April 2018) As CDISC compliant submissions become increasingly expected,...
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July 28, 2016
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
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
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
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
It's critical for biostatistics and data management to be closely aligned and working effectively together. The...
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February 26, 2016
Remember the early days of Electronic Data Capture? Those first systems, which were revolutionary for their time...
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December 1, 2015
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
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
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
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
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
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
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
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
During a recent DIA webinar on reinventing the clinical trial, Laurie Halloran (President of the Halloran Consulting...
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July 24, 2014
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
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
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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