Clinical Research Services
Reliable, accurate, on-time results from an experienced team
You can rely on decades of past experience of VivaQuant's staff in providing products and services to help pharmaceutical companies and medical device firms bring products to market faster and more predictably. We understand the regulatory and compliance landscape and can help you navigate the sometimes tortuous path to assessing the cardiac safety of your product.
Whether you need to assess interval changes, arrhythmia liability, arrhythmia burden, or restitution, VivaQuant is committed to providing the most accurate results possible, in the shortest time, and at a cost-effective price. We are a preferred ECG core lab partner for:
- Medical devices
- Pharmaceuticals
- Health researchers
The Rhythm Express Platform
VivaQuant offers pay-per-use online access to the AE-1010 software. This option provides the following benefits:
- Minimizes upfront capital costs for purchase of software licenses
- The AE-1010 software is hosted on a controlled hardware/software server configuration that is optimized for performance and stability
- Software validation efforts for GLP use can be limited to user testing with your specific data and workflow
Concentration Effects Models for Early Phase Arrhythmia Liability Assessment
We provide concentration effects modeling for customers desiring to obtain a thorough QT (TQT) waiver, or for full TQT studies. A recent publication in Clinical Pharmacology and Therapeutics documents the performance of our interval measurement algorithm and concentration effects models, demonstrating a 22 percent improvement in accuracy. This additional accuracy could potentially facilitate a clear decision on arrhythmia liability vs. a less accurate result that may lead to additional expensive studies or lack of FDA approval to proceed. Click here for a copy of the paper.
Example CE model created by VivaQuant comparing VivaQuant CEM results (RE) to FDA results on a publicly available database.
Clinical Assessment of Multi-channel Block
VivaQuant can assess multi-channel block through the assessment of early repolarization (J to T-peak) and late repolarization (T-peak to T-end) T-wave sub-intervals. This is most appropriately performed on multi-channel ECG recordings such as the 12-lead recordings often performed in clinical research studies. Multi-channel ECG input is reduced to a composite spatial magnitude (SM) lead projecting all signal energies in the positive direction to enhance signal stability and feature detection. The results can be input into concentration effects modelling to further refine liability assessment.