2 min read
Reflections from ASCO 2025
Clinical Impact, Technology Innovation, and Emerging Advances in Cell and Vaccine-Based Oncology
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3 min read
Project Optimus Explained: Why the FDA is Shifting Away from Maximum Tolerated Dose in Oncology
June 17, 2025
Historically, oncology drug development followed a straightforward principle: identify the highest dose patients could tolerate without unacceptable side effects, then use that dose in subsequent trials and clinical practice. This maximum tolerated dose...
3 min read
Monthly FDA Guidance and Regulatory News Review - May 2025
June 12, 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
Staying Ahead of Regulatory Change: CMC Strategies for Cell and Gene Therapy Development
June 11, 2025
The regulatory landscape for cell and gene therapies (CGTs) is shifting fast. From increased scrutiny on Chemistry, Manufacturing, and Controls (CMC) to operational challenges at the U.S. Food and Drug Administration (FDA), sponsors must be prepared to...
4 min read
Marketing Application Publishing Best Practices
June 5, 2025
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.
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The FDA recently released a draft guidance on the use of multi-regional clinical trials (MRCTs) in oncology research.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...