Industry Insights
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Accelerated patient recruitment reduces clinical trial time by 25%
9/13/2000
Patient recruitment continues as the major challenge to the timely completion of clinical research trials...
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Selecting A Vial Container Closure System With The DeltaCubeā¢ Modeling Platform
Understand a system approach that facilitates data-driven selection and optimization of vial container closure system components.
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FDA FY2019 Warning Letters: A Closer Look At Drug Manufacturers
2/28/2020
Part two of this series takes a deep dive into the types of drug manufacturers that received warning letters and their locations, including data on how frequently the FDA recommends that firms hire qualified consultants and its request for “independent assessments” in warning letters.
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Do You Have an FDA Audit Process in Place?
2/23/2023
Ease the stress of a U.S. Food and Drug Administration (FDA) visit to your facility by learning how to maintain a state of FDA audit process readiness.
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A Risk-Based Approach To Environmental Monitoring & Control For Pharmaceutical Distribution
10/20/2016
Over the past few decades, many companies have spent time and capital investment in assessing and mitigating risk factors across the extended supply chain. However, even for those companies that have designed and implemented state-of-the-art operational supply and logistics networks, there is always risk that products may be impacted by variations in temperature, humidity, or other deviations from ideal conditions at any stage across the chain of custody.
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Strategies For Implementing An Improved Change Management Process
1/4/2019
In the first article of this two-part series, we provided an overview of a co-creation model for change management and the tools and methodologies that form the foundation for improved change management. This second part will look at strategies for implementing an improved change management process.
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Enabling Quality Executives To Spearhead Quality 4.0
12/14/2022
Quality 4.0 transformation has gained momentum over the last few years, and most companies are not seeing their expected results. Learn about an opportunity to change this ongoing pattern.
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Challenges in Adopting Drug Delivery Device Technology
10/3/2012
In my first column, I described the history of drug delivery devices and explained why they are likely to play an increasingly important role in the pharma/biopharma industry. This column focuses on some of the challenges the industry faces in adopting more advanced drug delivery technologies, as well as advanced injection devices — as this is where a lot of current activity is directed.
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Biopharma Deal-Making In 2022: Key Trends
3/11/2022
Strategic partnerships and alliances in biopharma have become an even more important means of accessing new capabilities. This article examines key recent trends in biopharma deal-making and M&A, and how those will inform related activities in 2022.
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IT in the Lab: Would You Select a Business Partner Based on System Functionality?
8/4/2000
Implementation services are crucial to a project's success...