November 10, 2023
Independent data monitoring committees review unblinded clinical trial data and issue recommendations to designated...
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September 25, 2023
As the pressure to reduce timelines rises across the industry, independent data monitoring committees (IDMCs) — which...
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September 13, 2023
Independent data monitoring committees (IDMCs) review ongoing clinical trial data to make recommendations regarding...
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June 13, 2022
The International COVID-19 Data Alliance (ICODA) was formed to address the challenge of generating rapid and rigorous...
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December 21, 2020
2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog...
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August 11, 2020
While there is increasing optimism about the discovery of a COVID-19 vaccine, one of the less talked about aspects of...
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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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March 20, 2019
No one plans to have a trial whose data collection needs rescuing. However, lagging enrollment rates, operational...
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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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July 2, 2018
A number of the Cytel team were in Amsterdam, 3rd- 6th June 2018 for the PSI Conference. This year’s conference was...
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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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February 28, 2018
There is a consensus in the industry that data on rare diseases is limited, incomplete, and difficult to find or...
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November 15, 2017
Each year Halloran Consulting Group hosts‘CORE’ (Clinical Operations Retreat for Executives) as a forum for industry...
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October 27, 2017
In this blog, we share the second part of our interview with Bob Beckman, about a design concept for a confirmatory...
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August 2, 2017
As a biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and...
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July 11, 2017
The Adaptive Designs and Multiple Testing Procedures Workshop (ADMTP), the first joint meeting of the Adaptive Designs...
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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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February 15, 2017
Outsourcing solutions should never be a one size fits all process, and smaller and emerging biopharma companies may...
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February 6, 2017
CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher...
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December 21, 2016
December 18th 2016 was a significant date for the pharmaceutical industry and regulatory submissions. For trials which...
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December 20, 2016
Data Standards play a crucial role in structuring and promoting long term value of clinical data. Clinical Data...
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December 6, 2016
The management of quality clinical data collection is built on a number of core essentials- including project...
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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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June 14, 2016
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 19, 2016
The explosion in healthcare information and “big data “has been one of the most written about topics in the last few...
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May 12, 2016
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
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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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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August 10, 2015
When approaching a Phase 3 clinical trial, the need to ‘de-risk’ the massive investment often leads sponsors on a quest...
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