Explore First: How a Stepwise Approach to QTc Studies Reduces Time, Cost, and Regulatory Risk

A smarter, data-driven approach to QTc analysis can accelerate your development timeline while minimizing costs and regulatory risk. Traditional models often rely on a one-size-fits-all solution—an approach that can either miss opportunities for streamlined TQT studies or underestimate the need for more robust analysis.

On the contrary, a stepwise strategy that begins with an exploratory concentration-QTc analysis can help chart a more efficient and cost-effective course. By pairing early insights into your data with program goals, you can determine whether to pursue a waiver, run a focused TQT study, or build a complex model only when truly necessary.

In this webinar, Certara experts will break down this approach and provide insight into how evolving regulatory expectations are shaping QTc evaluation:

• Patrick F. Smith, PharmD – SVP, Translational Science
• Adekemi Taylor, PhD – VP, Regional Lead USA, Division 1, Quantitative Science Services
• Kara Schmelzer, PhD – Sr. Director, Consulting