A pioneer in early-phase cardiac safety assessment
PhinC is a pioneer in QT/QTc analysis using a concentration–response approach,
with intensive ECG collection from first-in-human through ICH E14-compliant study designs.
Purpose: Make earlier decisions, reduce costs, and secure your regulatory strategy.
Rethinking cardiac safety with a Concentration–Response approach
The TQT study is costly and can only be conducted once the therapeutic dose is well established. The C–R approach leverages all ECG data collected in Phase I alongside systemic exposure, to assess QTc prolongation risk earlier and adapt monitoring accordingly.
Make earlier, data-driven decisions
Assess QT/QTc risk as early as FIH using robust C–R modeling.
Cost optimization
Optimize your resources by limiting the need for a dedicated TQT study.
Defensible strategy
Deliverables aligned with ICH E14, supported by a clear rationale for health authorities.
QT/QTc analysis: leveraging intensive ECG data alongside exposure
The concentration–response analysis simultaneously considers all ECG measurements and drug exposure. It provides essential predictions to assess the risk of QTc prolongation.
- ✓C-R Model QT/QTc vs concentration, with control of confounding factors.
- ✓Predictions of QTc prolongation risk at the target therapeutic dose and at higher exposure levels.
- ✓Decision on the need for a dedicated TQT study and on the monitoring strategy.
- ✓Report ready to support your regulatory interactions.
QT/TQT study design: optimize without compromising compliance
PhinC supports you in designing QT/TQT studies, optimizing costs, and ensuring optimal, controlled execution in full compliance with regulatory requirements.
- ✓Strategy for intensive ECG collection (timing, replicates, conditions).
- ✓Analysis plan (C–R modeling, sensitivity analyses, decision criteria, traceability).
- ✓Recommendations to adapt monitoring if a signal emerges.
- ✓Support for regulatory submissions and agency queries.
Cardiabase-Banook, a partner of choice for TQT studies
For state-of-the-art, compliant TQT studies, we rely on a specialized partner for ECG acquisition, processing, analysis, reporting, archiving, and overall monitoring.
How our partnership strengthens your studies
- ✓Standardized and controlled ECG acquisition
- ✓Processing & analysis with full traceability and quality control.
- ✓Reporting tailored to audit requirements.
- ✓Secure archiving and data lifecycle management.