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Veristat Expands Global Regulatory Expertise
Meet Daphne Smyth, Vice President, Global Head of Regulatory Affairs
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The Human Factor: Why Team Integration Makes or Breaks Marketing Applications
March 25, 2025
In the complex world of new drug applications (NDAs) and marketing authorization applications (MAAs), success often hinges not on technical expertise alone, but on how well teams work together. While each submission brings its own unique challenges, one...
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Evaluating Adaptive Trials: Do They Align with Your Study’s Goals and Requirements?
March 18, 2025
Innovative clinical trial approaches, including adaptive study designs, can play a key role in improving the efficiency of new drug development within biotech and pharma clinical research.
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Monthly FDA Guidance and Regulatory News Review - February 2025
March 12, 2025
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
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Unlocking Potential: Taking a Statistics-driven Approach to Clinical Trial Planning
February 27, 2025
Clinical trials are complex, and even well-designed studies may encounter challenges in demonstrating statistical significance.
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Timeline Mastery: The Strategic Backbone of Marketing Application Success
February 24, 2025
In the intricate dance of preparing marketing applications, the timeline serves as a choreographer, directing countless moving parts into a cohesive submission. Understanding how to craft, manage, and adapt this essential document can mean the difference...
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The Right Track for Data Management Success
February 13, 2025
Data management plays a formative role in driving clinical development and supporting sponsors' success. Veristat’s flexible global data management approaches enable even the most complex clinical data challenges to be overcome quickly and successfully,...
4 min read
Monthly FDA Guidance and Regulatory News Review - January 2025
February 9, 2025
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
3 min read
Multi-Regional Clinical Trials: The Latest Guidance from FDA
January 24, 2025
Planning and designing clinical trials conducted in multiple geographic or regulatory regions
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Monthly FDA Guidance and Regulatory News Review - December 2024
January 14, 2025
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...