Now On-Demand: Explore First: How a Stepwise Approach to QTc Studies Reduces Time, Cost, and Regulatory Risk
Originally aired: Thursday, July 24, 2025 | 11 AM ET
Access this exclusive webinar recording to learn how a smarter, stepwise C-QTc strategy can help you streamline cardiac safety evaluation—reducing cost, time, and regulatory uncertainty.
Traditional QTc strategies often rely on a one-size-fits-all approach—risking unnecessary studies or missed opportunities for simplification. In this session, Certara experts share how an exploratory, data-driven path can help you:
- Determine when to justify waivers
- Design focused TQT studies
- Build complex models only when necessary
You’ll also gain insights into evolving regulatory expectations—and how to align your QTc approach for stronger decision-making and smoother submissions.
Key Takeaways:
- Why early ECG collection is key to enabling exploratory C-QTc analysis
- How to decide between waiver, focused TQT, or full modeling strategies
- What regulators expect and how to stay one step ahead
- How a tailored approach helps reduce cost, time, and downstream risk
Featuring:
- 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
Access the recording now and discover how to elevate your QTc strategy.
