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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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2 min read

Bridging Science and Regulatory Success with Medical Writing

As medical content evolves from focusing on technical and scientific information to also incorporating patient- and consumer-targeted communication, and as the range of regulatory documents expands, medical writing remains a highly valued and in-demand...

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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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2 min read

Biostatisticians: Ensuring the validity, reliability, and interpretability of clinical trial data

Discussion with Erin Mathias, Sr. Director, Global Biostatistics

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4 min read

Monthly FDA Guidance and Regulatory News Review-September 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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