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Thorough QT/QTc (TQT) Studies
With extensive experience assessing cardiovascular safety across all major indications, CoreLab Partners is the core lab of choice when selecting a centralized, cardiac-safety partner to support your next TQT study. Our expertise and knowledge base includes intensive QTc trials in therapeutic indications and drug classifications where a formal TQT is not a viable option, ie, oncology.
A Higher Level of Expertise
Corelab Partners’ medical and scientific team has strong experience in successfully designing and supporting TQT studies, and the full range of clinical pharmacology programs. Our focus is beyond the single study and across the entire cardiac safety profile of the study compound from Phase I–IV. This is important when developing compounds across a wide range of therapeutic indications. Our US board-certified cardiology team includes resources with pediatric cardiology expertise.
We offer proven global capabilities and experience, having successfully completed the first ever regulatory mandated TQT study in the Asia Pacific Rim and the first TQT study for a Japanese new drug application (NDA).
Services include:
- Expert support throughout the study and regulatory submission (FDA, EMA & PMDA)
- TQT study design
- Full protocol and SAP development
- Advanced automated solutions
- Safety data monitoring during the study
- Statistical analysis and expert report writing
- Advanced ECG data capture and analysis methodologies and equipment
- Quality assurance including customized reader variability reports
- WebHeart—industry leading, cardiac safety management platform
- Site training and 24/7 support
As a clinical trial sponsor in today’s heightened regulatory environment, you need to ensure drug safety. That’s why it is imperative to partner with a core lab that you can trust will deliver quality and consistent ECG data—in real time.
Contact CoreLab Partners to learn more about how our scientific and medical expertise can help you design, conduct and analyze your next TQT trial. Speak with a cardiac safety expert at 800.333.6460 or via email at info@corelabpartners.com.
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