The industry is examining strategies to move away from the mandatory later stage TQT study and provide cardiac safety insight earlier in the development process with intense ECG Phase I studies (learn more). ERT has been conducting Intense ECG collection in Phase I since the year 2000, including Phase 1 Clinical Pharmacology Unit (CPU) selection, service enhancement, and PK-PD analysis in Single Ascending Dose/Multiple Ascending Dose studies (SAD/MAD), the most promising methods under consideration to replace the TQT study. ERT has developed specialized services to assist sponsors, CROs, and CPUs in executing efficient Phase I cardiac safety studies. We can quickly deploy and service any needed ECG, Holter, or ABPM equipment to ensure device and algorithm consistency. Most importantly, we provide centralized overread, analysis, statistical, and other consulting services to ensure the highest quality data results, as well as centralized data management and formatting of data for submission to regulators. CPUs can also leverage their own equipment investments in Phase I studies while using ERT’s centralized services for data management. Our flexible approach maximizes study ROI while delivering rigorous QA/QC, multiple checks on the data, and an industry leading SD of 5-6 ms.

Optimize protocol design, fulfill requirements for TQT studies, support Phase I CPUs in intense ECG studies with PK-PD analysis, and ensure accurate regulatory submission

In our complex regulatory environment, you need a cardiac safety expert to rely on from Phase I and when deciding to undertake trials such as a Thorough QT/QTc (TQT). At ERT, we help you stay in compliance while focusing on ways to alleviate your process burdens. Having conducted more than 1,000 Phase 1 studies and over 220 TQT studies supporting 87 new drug approvals, we have the expertise, innovative approaches in technology and analysis, the highest quality of data, and world renowned consulting experience that our sponsor and CRO partners depend on, study after study.

ERT has developed specialized services to assist sponsors, CROs, and CPUs in executing efficient Phase I cardiac safety studies. We can quickly deploy and service any needed ECG, Holter, or ABPM equipment to ensure device and algorithm consistency. Most importantly, we provide centralized overread, analysis, statistical, and other consulting services to ensure the highest quality data results, as well as centralized data management and formatting of data for submission to regulators.

Optimize protocol design, fulfill requirements for TQT studies, support Phase I CPUs in intense ECG studies with PK-PD analysis, and ensure accurate regulatory submission

In our complex regulatory environment, you need a cardiac safety expert to rely on from Phase I and when deciding to undertake trials such as a Thorough QT/QTc (TQT). At ERT, we help you stay in compliance while focusing on ways to alleviate your process burdens. Having conducted more than 1,000 Phase 1 studies and over 220 TQT studies supporting 87 new drug approvals, we have the expertise, innovative approaches in technology and analysis, the highest quality of data, and world renowned consulting experience that our sponsor and CRO partners depend on, study after study.

Not every heartbeat is the same.
Leverage EXPERT QT™ for our experience, unique analytics and
to potentially replace a Thorough QT study…

Expertise in Thorough QT Studies

ERT understands the need for consistent QTc measurement as well as the importance of identifying QTc prolongation during drug treatment.  Our core lab provides the real-time collection of consistent, quality ECG data – a critical aspect to assessing your drug’s cardiac effect. We provide full TQT study support, including:

  • 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

At the completion of each trial, we provide you with XML files and full support in uploading ECG digital files to the FDA ECG Warehouse, a required regulatory submission for TQT and other pertinent trials.

Expertise in Thorough QT Studies

We provide full TQT study support, including:

  • 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

We’ve conducted more than 1,000 Phase 1 studies (and over 220 TQT studies supporting 87 new drug approvals)

Device Recommendations for Phase I Trials

Innovations in Phase I Studies

ERT is constantly working with sponsors, CROs and CPUs to identify new technologies and approaches to optimize cardiac safety in Phase I and TQT studies. From new wireless ECGs and tablets to ease site burden and make collection easier to algorithms like QT Guard Plus™ that provide analysis alternatives for equivocal QT signals, ERT reinvests every year in innovation to make sure that you get the most of your sites and your data.