Bioclinica offers full TQT study support, including concept and protocol design, ECG management and analysis and regulatory reporting. Bioclinica has supported innovative and conventional TQT trial designs in collaboration with members of sponsor and regulatory team members. We offer proven global capabilities and experience, having successfully completed the first ever regulatory mandated TQT study for a Japanese new drug application (NDA) and the first TQT study in China.
Bioclinica's Full TQT Services include:
- Study design with full protocol and SAP development
- Advanced ECG data capture, analysis methodologies and equipment
- Analysis by US board-certified cardiologists
- Expertise and guidance for regulatory submission (FDA, EMA, PMDA, and CFDA)
- Quality assurance including customized reader variability reports
- Interim cohort reporting
- Support capabilities for data safety monitoring boards
- Expert QT report writing
- WebHeart platform for cardiac safety data management
- Site training and continuous project support
- Support in identifying clinical pharmacology research units
From a therapeutic and regulatory perspective, Bioclinica appreciates that not all compounds can complete a formal TQT. Our medical and scientific teams have the experience and regulatory awareness of how best to approach addressing the QT cardiac safety considerations where conventional TQT studies are not possible.
In today's heightened regulatory and R&D environment, it is imperative to partner with a core lab that can deliver quality and consistent ECG data and has capabilities and experience in the successful design, conduct and submission of TQT and intensive QT data.