Definitive QT Evaluation – Clinical and Operational Considerations

Session information:

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.

Borje Darpo, M.D., Ph.D.

Chief Scientific Officer at Clario

Dr. Borje Darpo, Clario’s Chief Scientific Officer, is board-certified in cardiology and internal medicine. He completed his cardiology training at Sahlgrenska University Hospital, Göteborg and was appointed Associated Professor at Karolinska Hospital, Stockholm in 2000. Borje held various positions within CROs and pharmaceutical industry.

Borje represented the European pharmaceutical industry on the ICH E14 Expert and Implementation Working Group (2000 – 2008). He led the IQ-CSRC study, which validated applying early stage exposure-response analysis data to replace the TQT study; contributing to the revision of ICH E14 and allowing this approach to replace the TQT study.

Justin Couture

Director, Clinical Operations at Dr. Vince Clinical Research

Justin Couture has been a nationally registered paramedic for 14 years with a decade of work specifically in clinical research. Couture has held several roles in the medical research field ranging from direct patient care to clinic supervision and project management. He is advanced cardiovascular life support (ACLS) certified and has completed graduate-level education in organizational leadership.

Michael Hirschman

Lead Project Manager at Clario

Mike Hirschman is a Project Manager at Clario with over 10 years of experience managing early-phase clinical trials. He leads a team of Project Managers who specialize in end-of-study statistical analysis and regulatory submissions. With expertise in QT submission requirements, Mike supports sponsors in navigating the complexities of cardiac safety study operations; from initial study scoping through to final regulatory submission.