Thorough QT/QTc Trials
You need a partner who has substantial experience and can help guide you through the regulatory process. In ERT, you have that partner: We've conducted more than 160 TQT studies and have more experience than any other ECG centralized core lab.
ERT's centralized core lab provides real-time collection of consistent, quality ECG data - a critical element in the accurate assessment of a new drug's cardiac effect.
While the regulatory landscape is growing more complex, you can count on our experts to guide you through it.
ERT provides full TQT study support:
- Consultation and study design
- Phase I unit identification and selection
- Provisioning of equipment and supplies
- Site training
- ECG processing, data management, reconciliation and reporting
- Quality control/quality assurance
- Comprehensive Project Assurance methodology
- Statistical and medical reporting
- Authoritative regulatory support
FDA XML files are provided at the completion of each trial. ERT provides full support for uploading ECG digital files to the FDA XML Warehouse for Thorough QT/QTc (TQT) and other pertinent trials required for regulatory submission. Plus we offer preferred pricing for sponsor-only warehouse access and use.
