June 15, 2022
For years CDISC data standards implementers have struggled to find good implementation examples and use cases beside...
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April 25, 2022
I am excited to see you all at the CDISC Europe Interchange, April 27 – 28 but unfortunately, it will be a virtual...
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February 18, 2022
Data is the most crucial asset of any clinical trial and hence, sponsors cannot jeopardize collecting clean...
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February 17, 2022
It is a common perception that the role of a Data Manager is only to perform what we call “Data Cleaning”; making sure...
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February 11, 2022
Adopting data standards such as CDISC in the early phase of clinical drug development contributes to the consolidation...
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February 9, 2022
Data is the cornerstone of any clinical trial and is used to ultimately drive the decision-making process related to...
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January 26, 2022
In this edition of the Career Perspectives series, I interview Jessica Bhoyroo, Cytel Clinical Data Manager based in...
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January 25, 2022
In this blog, I share some experiences we recently had during an FDA submission Cytel performed for a sponsor after...
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December 15, 2021
Recently, on November 29 I received an email from CDISC announcing an important update for both SDTM and ADaM CDISC...
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November 30, 2021
The FDA “Real-Time Oncology Review (RTOR)”[1] is an “FDA project started in 2018 to facilitate earlier submission of...
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October 5, 2021
Traceability is crucial in all steps of clinical data handling, from data collection to final analysis. The importance...
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August 31, 2021
For years, I have been telling the recruiters at Cytel to be wary of candidates claiming to have a CDISC Certification...
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July 30, 2021
I had recently (for the first time) the pleasure and honor to attend a virtual meeting with the FDA, a pre-NDA Type-B...
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July 20, 2021
Anil Golla is Vice President, Functional Service Provision (FSP) at Cytel. After 17 years of working at pharmaceutical...
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June 14, 2021
ACDM’s (Association for Clinical Data Management) eDigital data management expert group (DMEG) focuses on driving...
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April 26, 2021
As we all continue to take necessary precautions against the spread of COVID-19 virus, this year again the CDISC EU...
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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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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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January 19, 2021
As we enter 2021 with new COVID-19 vaccines and greater optimism about the pipeline of drugs and devices positioned for...
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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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October 13, 2020
The combination of greater access to electronic health records, bigger electronic claims datasets, and the need for...
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October 7, 2020
With the rise in digital technologies, there has been an explosion in the volume and type of data sources. We can...
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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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January 8, 2020
In clinical development, data is the vital ‘foundation’ that supports your programs. To successfully bring a promising...
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December 16, 2019
Cytel Inc. and Axio Research joined forces in June 2019, expanding our ability to solve the most complex analytical...
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December 10, 2019
In association with Statisticians in the Pharmaceutical Industry (PSI) , UCB and Cytel hosted a symposium on September...
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November 27, 2019
At the 2019 Challenges in Rare Diseases Clinical Trials Symposium and East training, Cytel partnered with Alexion to...
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September 12, 2019
"If you went to bed last night as an industrial company, you're going to wake up today as a software and analytics...
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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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April 10, 2019
In this blog, Jonathan Pritchard, Director Business Development at Cytel, draws on his experience in commercial,...
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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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June 14, 2018
In this blog, Paul Fardy, Executive Director of Data Management at Cytel shares his thoughts on how the data manager...
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April 18, 2018
Our recent Clinical Biometrics Survey explored the views of respondents from across the statistical programming,...
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March 14, 2018
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
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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August 2, 2017
As a biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and...
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