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Regulatory Consulting (2)

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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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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Successful DMC Services for Complex Hematologic Cancer Trial

Learn how Veristat's expert biostatistics team worked with a longstanding global biopharma sponsor to navigate complex Data Monitoring Committee (DMC) requirements for a challenging hematologic cancer trial. Collaborative efforts led to successful trial...

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Understanding the Critical Role of Data Monitoring Committees in Clinical Trials

Learn how Veristat's expert teams develop and organize various independent Data Monitoring Committees (DMCs) to ensure patient safety and trial integrity. Discover the crucial role DMCs play in monitoring trial conduct, assessing risks and benefits, and...

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4 min read

Monthly FDA Guidance and Regulatory News Review - August 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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