8 min read
Monthly FDA Guidance and Regulatory News Review - July 2026
This July 2026 regulatory update focuses on the FDA finalizing six guidances that addresses antiviral next-generation...
1 min read
Veristat is excited to attend the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop being sponsored by the ASA Biopharmaceutical Section in cooperation with the FDA Statistical Association.
This conference includes invited sessions co-chaired by statisticians from industry, academia, and the FDA over two days. In addition, short courses on related topics are offered the day prior to the workshop.
Many of the exciting topics that will be discussed at this event include:
- Data Visualization in the Life Sciences
- Futility Analyses in Confirmatory Clinical Trials: Methods and Procedures
- Bayesian Adaptive Designs for Immunotherapy and Drug Combination Trials
- Advancing Drug Development Through Precision Medicine and Innovative Clinical Designs: Concepts, Rationale, and Case Studies
- Defining Treatment Effects in Randomized Trials
- Better Characterization of Disease Burden by Using Recurrent Event Endpoints
- Sample Size Re-Estimation in Regulatory Applications: Experiences and Lessons Learned
- Recent Advancements in Statistical Methods and Tools for Go/No-Go Decision-Making
Schedule A Meeting with Veristat
To speak with a member of our biostatistical team either at the workshop or anytime that is convenient for you, simply fill out the form on the right hand side of this page.
Read our Adaptive Design Success Story
"Operationalizing A Complex Adaptive Design | Accelerating A Go/No-Go Decision "
A clinical-stage biopharmaceutical company came to Veristat with a complex statistical methodology for running a phase II adaptive design trial with the goal of expediting a go/no-go decision for a specific patient population. The sponsor's challenge was that they didn't fully understand the complex methodology enough to explain it nor design the actual trial.
Learn how and why Veristat was able to implement the design and help the sponsor reach their go/no-go decision quickly.
