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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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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...

READ MORE