Featured Articles
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The Model-Based Approach: A Better Way To Forecast Enrollment
1/15/2019
Compared to conventional approaches, a model-based approach to enrollment forecasting provides a more realistic assessment of the possible risks and outcomes for any given scenario, by accounting for the nonlinearity and randomness of real-life enrollment processes. In addition, a model-based approach offers many more advantages other than more realistic expectations.
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Creating A Common Language: Forging Statistical And Clinical Collaborations
1/15/2019
This article will provide helpful pointers from Paul Terrill, Director of Strategic Consulting at Cytel to ensure smooth communication between statistical and clinical stakeholders.
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Data Management Fundamentals For Your Next Clinical Trial
11/9/2018
Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process related to the development candidate. Therefore, for any sponsor, paying close attention to the data management aspects of clinical operations should be paramount. The principles of data management are simple and well-founded. However, the application of these principles needs careful consideration, depending on various scenarios and the size of the organization. When implementing data management for your trial, it is critical to plan ahead and fully understand all the steps and activities involved.
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What Makes A Good Data Manager? Infographic
11/9/2018
Data managers need to equip themselves with skills to make sense of an ever-expanding world, while maintaining adherence to core principles of safety and efficacy.
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What Makes A Good Data Manager?
11/9/2018
The shift from on-site monitoring to remote monitoring has given the data manager an increased responsibility for looking at the data in real time and to allow decisions to be made on a site and patient level on an ongoing basis. This article discusses what makes a great data manager in today’s drug development environment.
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In The Midst Of This: The Data Management Perspective On The Interim Analysis
11/5/2018
Patti Arsenault, Cytel's Global Head of Data Management, shares her thoughts on the three core elements important for the success from the data management standpoint - effective timeline management, thoughtful database design, and a proactive approach to data cleaning.
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Decisions For Your Next Trial: When To Adopt The CDISC Data Standard
11/2/2018
Trial sponsors must carefully plan their data consolidation and analysis strategies not only in preparation for CDISC-compliant submissions, but to respond to market influences and evolving clinical partnership models.
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Data Science: Bridging The Gap Between Controlled Experiment And Real-World Data?
10/31/2018
Results from a recent Deloitte survey explored if data science could be about to revolutionize the regulatory approval of new drugs.
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Critical Operational Considerations For Interim Analyses
10/31/2018
Highlights from Adam Hamm, Director Biostatistics at Cytel, presentation on best practices and operational considerations for adaptive designs and interim analyses.
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Addressing The Problem Of Feature Selection Using Genetic Algorithms
10/31/2018
In the new era of big and complex data, conventional methods of solving search problems are sometimes ineffective.Genetic algorithms provide a highly effective solution to many such problems, and therefore their popularity and adoption are on the rise.