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Clinical Trial Regulations

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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3 min read

FDA’s Draft Guidance for Data Monitoring Committees (DMCs)

How Veristat’s Proven DMC Expertise for Complex Trials Supports Patient Safety and Sponsor Success

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4 min read

Monthly FDA Guidance and Regulatory News Review - July 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

4 min read

Monthly FDA Guidance and Regulatory News Review - June 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

2 min read

Monthly FDA Guidance and Regulatory News Review - May 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

5 min read

Monthly FDA Guidance and Regulatory News Review - April 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