Conducting a definitive QT evaluation is a critical regulatory requirement for small molecule drug development. With evolving ICH guidance and increased interest in early phase QT strategies, biopharma companies face complex scientific and operational decisions that can impact timelines and approval outcomes.
In this webinar, experts from Dr. Vince Clinical Research and Clario will examine the clinical and operational components of QT evaluation, covering study design options, regulatory expectations and site-level execution. Topics will include FDA requirements for defining QT evaluation; current pathways, including early phase QT assessments and Thorough QT (TQT) studies with waiver potential, and site-level operational best practices for Holter monitoring, ECG data collection and submission readiness from both a data and documentation standpoint.
Attendees will gain a holistic understanding of the end-to-end process for QT evaluation, including case studies and regulatory insights that inform smarter development decisions.
Key Takeaways:
- Key considerations for determining whether early phase QT data may support regulatory waiver of a standalone TQT study
- Impact of recent ICH S7B/E14 revisions on clinical and non-clinical QT evaluation pathways
- Operational best practices from DVCR, including volunteer education, Holter monitor placement, lead verification protocols, centralized ECG collection and data transfer from Surveyor
- Regulatory deliverables and submission milestones for a cardiac study, including key datasets and Clario’s QT submission checklist
Whether planning a first-in-human trial or preparing for NDA submission, this session will equip biopharma companies with the insights needed to navigate QT evaluation confidently and efficiently.