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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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Monthly FDA Guidance and Regulatory News Review - December 2024
January 14, 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...
2 min read
Bridging Science and Regulatory Success with Medical Writing
December 16, 2024
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...
3 min read
Monthly FDA Guidance and Regulatory News Review - November 2024
December 15, 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...
3 min read
Monthly FDA Guidance and Regulatory News Review-October 2024
November 13, 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
Biostatisticians: Ensuring the validity, reliability, and interpretability of clinical trial data
November 6, 2024
Discussion with Erin Mathias, Sr. Director, Global Biostatistics
4 min read
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...