QT Investigations

QT investigation is a crucial component of the clinical development program for most compounds. With over 35 years of experience in supporting clients with these trials, Biotrial’s Core Lab can provide comprehensive assistance at every stage of the project.

Whether this means including a QT investigation component within a phase I program, performing a dedicated Thorough QT (TQT) trial or implementing further measures within various Clinical Pharmacology or phase II-III trials, Biotrial’s Core Lab offers the required expertise.

Biotrial-Corelab-Qt-Ecg

In addition to designing QT elements of a phase I trial or dedicated TQT trials, Biotrial can assist in the specific Concentration-QT analysis.

Biotrial-core-lab-consulting-Qt-Investigation

Consulting & Design Services

Consulting & Design Services are offered by experts who help design your QT investigation in line with the compound profile & regulatory requirements, whether this requires a specific TQT trial or can be integrated into another clinical protocol.

This includes the interpretation of trial results as well as advice on the overall development plan for the compound.

Biotrial Core Lab Qt Site Support

Clinical Site Support & Equipment

Biotrial’s Core Lab provides state-of-the-art equipment and continuous staff support to optimize recording quality.

  • Worldwide shipment of 12-Lead ECG or Holter devices for collection of digital ECGs
  • Site training and 24/7 support for global site locations
  • Immediate replacement of any defective materiel
  • Recording quality of ECG Data monitored on a continuous basis

ECG Analysis & QT Measurement

Biotrial’s large pool of cardiologists are specifically trained in ECG reading using state-of-the-art software.

  • Optimized extraction of 12-lead 10-second ECG from continuous recordings
  • Various reading methods available (semi-automated, fully-manual, fully automated)
  • Thorough quality control and reduced variability
Biotrial Core Lab Qt Investigation

Data, Stats & Reports

All Data Management activities are covered by Biotrial SOPs in order to guarantee data quality, process efficiency & compliance.

  • Specific ECG database and data transfer according to sponsor file specifications
  • Provide individual ECGs in submission-ready format (XML) for FDA submission

Biotrial statisticians & medical writers have extensive E14 experience for implementing TQT Study analyses and reports.

  • PK/PD analysis, QT/RR relationship exploration
  • Concentration-QT analysis

Quality Assurance

Biotrial Core Lab Qc Policy

Cardiologist pool specifically trained to ECG over-reading

  • Large (adaptable according to the study specificities: ECG number, deadline, …)
  • Specifically trained
  • Continuous variability monitoring 

Continuous QC Policy

All data generated by the cardiologists are subject to an extensive and complete quality control guaranteeing an optimal quality at every step of your ECG project.

  • Coherence control performed on measurements and diagnosis
  • Intra/inter reader variability assessment
  • Quality Control 

Team

Project Manager

Main sponsor contact throughout the trial. Organizes all aspects of the project at Biotrial.

Technical Manager

In charge of technical elements: device selection and setup, user manual, central reading manual.

Readers

Selected from the pool of experts depending on the exam to be read.

Data Manager

Collects endpoints into the agreed DB format, transfers this to sponsor at agreed timepoints

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