Cross-Functional Collaboration: A Cornerstone of Successful Clinical Development
Complex therapeutic development requires deep integration across clinical, regulatory, statistical,...
Posts about
Clinical Trial Regulations (3)
Monthly FDA Guidance and Regulatory News Review - June 2025
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Demystifying eCTD 4.0: What You Need to Know
Electronic Common Technical Document (eCTD) submissions have transformed sponsor companies'...
Mastering a Global Approach to Medical Writing
Medical writing plays an essential role in clinical development and regulatory approval. As...
Planning Your IND: When and Why to Engage the FDA
Many sponsors underestimate how much support the Food and Drug Administration (FDA) can offer...
Project Optimus Explained: Why the FDA is Shifting Away from Maximum Tolerated Dose in Oncology
Historically, oncology drug development followed a straightforward principle: identify the highest...
Monthly FDA Guidance and Regulatory News Review - May 2025
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Staying Ahead of Regulatory Change: CMC Strategies for Cell and Gene Therapy Development
The regulatory landscape for cell and gene therapies (CGTs) is shifting fast. From increased...
Multi-Regional Clinical Trials: Key Recommendations for a Global Clinical Development Program
The FDA recently released a draft guidance on the use of multi-regional clinical trials (MRCTs) in...
Top 3 Tips for Choosing the Right Oncology CRO
The decision to partner with a Clinical Research Organization (CRO) is never taken...