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Biostatisticians: Ensuring the validity, reliability, and interpretability of clinical trial data
Discussion with Erin Mathias, Sr. Director, Global Biostatistics
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Monthly FDA Guidance and Regulatory News Review-September 2024
October 16, 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...
Successful DMC Services for Complex Hematologic Cancer Trial
October 10, 2024
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...
Understanding the Critical Role of Data Monitoring Committees in Clinical Trials
October 4, 2024
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...
4 min read
Monthly FDA Guidance and Regulatory News Review - August 2024
September 16, 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...
2 min read
Cancer Research Trends | Key ASCO 2024 Takeaways
August 28, 2024
Discussion with Gabriela Rosu, MD, Sr. Director, Global Medical Affairs
3 min read
FDA’s Draft Guidance for Data Monitoring Committees (DMCs)
August 28, 2024
How Veristat’s Proven DMC Expertise for Complex Trials Supports Patient Safety and Sponsor Success
4 min read
Monthly FDA Guidance and Regulatory News Review - July 2024
August 28, 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...
12 min read
Veristat Global Policy Insights Q2
July 10, 2024
Index: RECENT DEVELOPMENTS: EU | RECENT DEVELOPMENTS: US | other recent developments | Outlook
Topics in focus
4 min read
Monthly FDA Guidance and Regulatory News Review - June 2024
July 8, 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...