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Clinical Trial Regulations

1 min read

Evaluating Adaptive Trials: Do They Align with Your Study’s Goals and Requirements?

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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3 min read

Monthly FDA Guidance and Regulatory News Review - February 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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2 min read

Unlocking Potential: Taking a Statistics-driven Approach to Clinical Trial Planning

Clinical trials are complex, and even well-designed studies may encounter challenges in demonstrating statistical significance.

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1 min read

Timeline Mastery: The Strategic Backbone of Marketing Application Success

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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2 min read

The Right Track for Data Management Success

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,...

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4 min read

Monthly FDA Guidance and Regulatory News Review - January 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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3 min read

Multi-Regional Clinical Trials: The Latest Guidance from FDA

Planning and designing clinical trials conducted in multiple geographic or regulatory regions

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3 min read

Monthly FDA Guidance and Regulatory News Review - December 2024

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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3 min read

Monthly FDA Guidance and Regulatory News Review - November 2024

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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3 min read

Monthly FDA Guidance and Regulatory News Review-October 2024

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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