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Marketing Application Publishing Best Practices
Effectively managing the publishing of documents required for a marketing application submission can help accelerate the time it takes to bring your product to market.
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5 min read
Multi-Regional Clinical Trials: Key Recommendations for a Global Clinical Development Program
June 3, 2025
The FDA recently released a draft guidance on the use of multi-regional clinical trials (MRCTs) in oncology research. A well-planned MRCT can be an efficient approach to the global clinical development of a novel product, allowing for access to a wider...
3 min read
Top 3 Tips for Choosing the Right Oncology CRO
May 29, 2025
The decision to partner with a Clinical Research Organization (CRO) is never taken lightly—especially in oncology. With high complexity, accelerated timelines, and evolving regulatory expectations, the stakes in oncology drug development are uniquely...
3 min read
Ensuring Patient Safety and Data Integrity with Veristat’s DMC Expertise
May 27, 2025
Data Monitoring Committees (DMCs) play a vital role in clinical trials by providing independent oversight to ensure patient safety, maintain scientific validity, and uphold data integrity. With clinical trials becoming increasingly complex, especially...
3 min read
FDA Delays Push Biotech Companies to Rethink U.S. Drug Development Strategy
May 22, 2025
A growing number of biotech firms are questioning their long-standing strategy of initiating clinical trials in the U.S. first, as the Food and Drug Administration (FDA) continues to struggle with internal upheaval and reductions in staffing, leading to...
3 min read
Bayesian Study Designs in Early-Phase Oncology Trials
May 20, 2025
The development of innovative oncology therapies has evolved dramatically, moving beyond traditional chemotherapies to include immunotherapies, targeted agents, radiotherapies, and cell and gene therapies. As these new modalities emerge, the limitations...
3 min read
Monthly FDA Guidance and Regulatory News Review - April 2025
May 19, 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...
1 min read
Staying the Course: What FDA Staffing Reductions Mean for Drug Development Today
May 12, 2025
The U.S. Food and Drug Administration (FDA) is undergoing significant change. Recent announcements have highlighted budget constraints, hiring freezes, and reductions in force (RIFs) across federal health agencies, including the FDA. These shifts have...
2 min read
Unlocking the Promise of Radiopharmaceuticals: Safety, Strategy & Innovation in Clinical Trials
May 6, 2025
We’re hearing more and more about the value of radiopharmaceuticals in medicine today—but what does it take to ensure their safe and effective development throughout a clinical trial?
2 min read
Building Confidence in RWE: Delivering Smarter Regulatory Strategies
April 29, 2025
Real-world evidence (RWE) offers the potential to serve as a valuable tool in regulatory decision-making, offering insights derived from the real world that can complement traditional clinical trials. By capturing data from diverse sources such as...