You are here: Home Services Pharmacometrics and PK statistics QT/QTc analysis (TQT) for cardiac safety

QT/QTc analysis (TQT) for cardiac safety

PhinC helps you to take charge of and limit any additional costs during the QT process. We take measures in the ECG data analysis and study design phases, using pharmacometric and statistical tools.

Your Reliable Partner in Regulatory QT Studies

With several years of experience in the area, PhinC is a partner you can trust for your TQT study. We provide support during the design phase of the study and when formulating the protocols. We also perform the required regulatory statistics.

Our mission is to help you to submit a file that matches your goals, while complying with the Health Authorities’ requirements in accordance with ICH-14 guidelines. PhinC also offers Modeling & Simulation to complete the official file.

Optimize your Regulatory Studies (TQT) with Early Monitoring

A good set-up for QT studies relies on its conception. Therefore, it is essential to collect the most amount of information for the first-in-man studies through intensive ECG monitoring, using the same techniques as in TQT studies.

We use those preliminary QT outcomes to perform exploratory analysis in order to identify tendencies and sources of variability. We initiate preliminary PK/QT models, useful for predictions, which are essential for the early and efficient adaptation of your regulatory ECG monitoring plan.

Benefit from a Full TQT Service

In order to provide you with a turnkey service for TQT studies, PhinC has established a partnership with the best cardiac core lab in Europe, Cardiabase. Working with these cardiology experts ensures that you achieve state-of-the-art and regulation compliant TQT studies.

Cardiabase specializes in data acquisition, processing, analysis, reporting and archiving for digital and paper ECG and holter monitoring. To learn more about our partnership, click here.

Regulatory Concerns

In 2005, Health Authorities, through the ICH-E14 guideline, made cardiac safety a compulsory requirement for drug development, even for non cardiovascular drugs. Indeed, it has been demonstrated that drugs can provoke a QT prolongation which is an early warning sign of torsade de pointes (TdP) potentially leading to death.

The mandatory studies are called “thorough QT/QTc study” (TQT). They include heavy electrocardiogram (ECG) monitoring and data management, and require a high level of expertise in design of studies, analysis and interpretation of results.