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White Paper

C-QTc and C-QT Analysis: Replacing TQT Studies and Accelerating Cardiovascular Safety Decisions

C-QTc and C-QT Analysis: Replacing TQT Studies and Accelerating Cardiovascular Safety Decisions

Cardiovascular safety evaluation is critical in drug development, especially the risk of QTc prolongation linked to life-threatening arrhythmias. Traditionally, sponsors relied on costly, time-consuming Thorough QT (TQT) studies to meet ICH E14 requirements. Regulatory-endorsed C-QTc analysis—also known as C-QT analysis or concentration-QT analysis—offers a validated, model-based QT analysis alternative. By integrating ECG and PK data collection into early-phase trials, sponsors can generate regulatory-ready evidence, replace TQT studies, and reuse data across multiple programs. This approach delivers cost savings, accelerates timelines, and strengthens regulatory outcomes.

If TQT studies have slowed your path before, this whitepaper reveals the proven, regulatory-accepted C-QTc strategies that streamline cardiac safety evaluations—showing how you can replace traditional studies and unlock efficiencies across your entire development program.

 

Key Takeaways

  • Replace TQT studies with validated C-QTc or C-QT analysis strategies accepted by FDA, EMA, PMDA.
  • Embed high-quality ECG and PK sampling in early-phase studies to meet ICH E14 expectations.
  • Apply model-based QT analysis to optimize dose, labeling, and life-cycle planning.
  • Reuse a single cardiac safety dataset across multiple indications and submissions.
  • Address the difference between QT and QTc to strengthen regulatory credibility.

Benefits

  • Regulatory efficiency – Secure waivers for standalone TQT studies.
  • Cost & time savings – Avoid separate trials and leverage existing infrastructure.
  • Data reusability – Support multiple programs with one robust dataset.

“You’re not just collecting ECGs to check a box—you’re designing your study to answer the QT question in a way regulators will accept.” – Kara Schmelzer, PhD – Sr. Director, Consulting at Certara.

 

Bonus Access

This white paper contains access to our expert led on-demand webinar, which discusses how integrated C-QTc analysis can streamline cardiovascular safety, deliver faster approvals, and reduce cost.

Submit the form to gain expert guidance on embedding FDA/EMA-Ready C-QTc Strategies into early-phase trials for faster, safer decisions.

 

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