De-Risking the Neurology IND: Lessons from Early FDA Engagement
Developing therapies for neurological diseases represents one of the most challenging frontiers in...
Monthly FDA Guidance and Regulatory News Review - November 2025
November brought significant FDA activity, with new final and draft guidances—from Pre-RFD updates...
The ctDNA Clinical Trial Advantage: Why CRO Work Puts You on the Cutting Edge
In the rapidly evolving field of circulating tumor DNA research, being on the front lines of...
Early Detection vs. Overdiagnosis: The ctDNA Screening Paradox
The promise of circulating tumor DNA for early cancer detection comes with a complex paradox: the...
Monthly FDA Guidance and Regulatory News Review - October 2025
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Accelerate Neurology/Psychiatry Trial Success with Expert Guidance
Learn how our neuroscience team partner with sponsors across multiple therapeutic areas to...
Beyond Detection: How ctDNA Could Optimize Treatment Selection
The promise of circulating tumor DNA (ctDNA) extends far beyond simply detecting cancer; it also...
Targeted Indication Selection Using Simon 2-Stage Design
Learn how Veristat’s biostatistics and strategic consulting teams were able to work with a...
Monthly FDA Guidance and Regulatory News Review - September 2025
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
What RAPS Convergence 2025 Means for Sponsors Preparing Global Submissions
It was wonderful to connect with so many of our peers at RAPS Convergence 2025 in Pittsburgh. As...