Leverage our ongoing innovative cardiac safety solutions including devices, algorithms, integrated endpoints, risk monitoring, technology, process optimization & future trial strategies

Your Choice – The Right Approach Customized for Your Study

You are not limited by one approach when you partner with ERT on Cardiac Safety. With  innovative cardiac safety solutions and experience across  Phase I, TQT studies, and into Phase II-IV, ERT does not take a “one-size-fits-all” approach to cardiac safety for your program, sites or patients.

Wireless ECG / eCOA Tablet

With the complexities of clinical trials, sites are often overwhelmed by the number of devices, numerous training requirements, and multiple portals and logins to remember. Traditionally, studies that support both Cardiac Safety ECG collection services and electronic Clinical Outcome Assessments (eCOAs) require the deployment of multiple devices, frequently provided by two separate vendors that add logistics costs and increase overall trial inefficiencies. For sponsors and CROs that seek to collect ECG and eCOA data in the same study, ERT’s innovative solution delivers integrated value for sites. This advanced integration offers a multifunction ECG /eCOA solution at a single point of use, making the trial more efficient and easing the burden on sites, while also leveraging tremendous process, time and cost savings for sponsors as well.

Wireless ECG / eCOA Tablet

For sponsors and CROs that seek to collect ECG and eCOA data in the same study, ERT’s innovative solution delivers integrated value for sites. This advanced integration offers a multifunction ECG /eCOA solution at a single point of use, making the trial more efficient and easing the burden on sites, while also leveraging tremendous process, time and cost savings for sponsors as well.

QT Guard Plus™ for Quantitative T Wave Morphology Analysis

general-electric-logo-png-1024x1024 Drugs which produce Torsades de Pointes (TdP), a potentially fatal disordered heartbeat, often produce changes in the T-wave shape well before the initiation of arrhythmias. Recognizing the value of T-wave morphology assessment as a sensitive surrogate for proarrhythmia, GE Healthcare, known for innovative healthcare solutions, and ERT have teamed to introduce the 510(k) approved QT Guard Plus™ algorithm to the clinical trial industry. Using the standard 12-lead ECG, biopharmaceutical companies can perform quantitative analysis of drug induced changes in T-wave morphology – helping to identify drugs which have an effect on QTc, but which nevertheless are not proarrhythmic. QT Guard Plus can complement traditional QT studies and may also allow for smaller studies. This comprehensive method of using an independent assessment of T-wave morphology is set to improve cardiac safety while preserving the drug development pipeline (learn more).

QT Guard Plus™ for Quantitative T Wave Morphology Analysis

When would you use QT Guard Plus?

  • Phase I Assessment of T-wave morphology can help to de-risk a new agent or flag a proarrhythmic risk early
  • May be useful for drugs with an equivocal QT results:
    • One or two timepoints in TQT have ΔΔ QTc UCI > 10 ms
    • Positive slope in PK-PD modeling
    • Heart rate effect possibly confounding QTc analysis
    • Concomitant QRS prolongation confounding QTc analysis
  • If TQT study shows small signal (10-15 ms) but no other evidence of proarrhythmia
  • If an approved drug demonstrates a small QT signal to cause adverse labeling
  • On drugs which have wallowed during development due to an equivocal or small QT signal

QT Guard Plus™ for Quantitative T Wave Morphology Analysis

Drugs which produce Torsades de Pointes (TdP), a potentially fatal disordered heartbeat, often produce changes in the T-wave shape well before the initiation of arrhythmias. Recognizing the value of T-wave morphology assessment as a sensitive surrogate for proarrhythmia, GE Healthcare, known for innovative healthcare solutions, and ERT have teamed to introduce the 510(k) approved QT Guard Plus™ algorithm to the clinical trial industry. Using the standard 12-lead ECG, biopharmaceutical companies can perform quantitative analysis of drug induced changes in T-wave morphology – helping to identify drugs which have an effect on QTc, but which nevertheless are not proarrhythmic. QT Guard Plus can complement traditional QT studies and may also allow for smaller studies. This comprehensive method of using an independent assessment of T-wave morphology is set to improve cardiac safety while preserving the drug development pipeline (learn more).

Webinar: T-Wave Morphology Assessment in Cardiac Safety

This educational webinar will review the results of the poster presented by FDA at the American Heart Association’s Scientific Sessions on November 16, 2014 entitled “T-Wave Morphology Assessment in a Randomized Double-blind Crossover Study of Four hERG Potassium Channel Blocking Drugs.”  FDA representatives will also be on the webinar to answer questions after the presentation. Access webinar now.

When would you use QT Guard Plus?

  • Phase I Assessment of T-wave morphology can help to de-risk a new agent or flag a proarrhythmic risk early
  • May be useful for drugs with an equivocal QT results:
    • One or two timepoints in TQT have ΔΔ QTc UCI > 10 ms
    • Positive slope in PK-PD modeling
    • Heart rate effect possibly confounding QTc analysis
    • Concomitant QRS prolongation confounding QTc analysis
  • If TQT study shows small signal (10-15 ms) but no other evidence of proarrhythmia
  • If an approved drug demonstrates a small QT signal to cause adverse labeling
  • On drugs which have wallowed during development due to an equivocal or small QT signal

Centralized Ambulatory Blood Pressure Monitoring

Ambulatory Blood Pressure Monitoring (ABPM) is used in clinical trials for evaluation of efficacy and cardiac safety of both antihypertensive and non-antihypertensive drugs, as well as an endpoint for cardiovascular and cerebrovascular outcomes. Our ABPM technology offers an automatic, non-invasive device to measure blood pressure over an extended period of time, typically 24 hours. Our ABPM solution is an extension of ERT’s suite of integrated centralized cardiac safety solutions to support protocol compliance, improve data quality, reduce investigator workload, and improve the overall user experience at the investigative site ERT’s ABPM solution utilizes the Ambulo™ 2400, a lightweight durable ABP monitor that is worn for 24 hours to automatically measure systolic and diastolic blood pressure, mean arterial pressure, and pulse rate during the day and night.

Centralized Ambulatory Blood Pressure Monitoring

Our ABPM solution is an extension of ERT’s suite of integrated centralized cardiac safety solutions to support protocol compliance, improve data quality, reduce investigator workload, and improve the overall user experience at the investigative site ERT’s ABPM solution utilizes the Ambulo™ 2400, a lightweight durable ABP monitor that is worn for 24 hours to automatically measure systolic and diastolic blood pressure, mean arterial pressure, and pulse rate during the day and night.

Our EXPERT® Central Platform and My Study Portal™

ERT’s proprietary EXPERT® Central technology platform is a private clinical research cloud that powers centralized data collection, data management, and information exchange. The EXPERT Central platform is tailored for the unique requirements of ERT’s multiple endpoint data collection solutions and your unique protocols and desired user experience. My Study Portal™ is an easy-to-use system for real-time study data access as it is processed by ERT in EXPERT Central and for managing key study tasks anywhere in the world 24/7 – everything from ECG analysis results, report and tracings, site registration, queries to clinical study teams, and even online supply ordering. EXPERT Central’s structured database design also affords centralized surveillance to support risk-based monitoring and rapid integration with EDC and other third party eClinical data systems (learn more about My Study Portal).

Our EXPERT® Central Platform and My Study Portal™

ERT’s proprietary EXPERT® Central technology platform is a private clinical research cloud that powers centralized data collection, data management, and information exchange. EXPERT Central’s structured database design also affords centralized surveillance to support risk-based monitoring and rapid integration with EDC and other third party eClinical data systems (learn more about My Study Portal).

“In the current trial that I am study coordinator for, I am using three different clinical trial management systems, and My Study Portal is by far the easiest to use. Thank you!”

– Site Investigator

Centralized Data Surveillance of Cardiac Safety Studies to Support Risk-Based Monitoring

ERT now offers early, proactive trending of site performance on Cardiac Safety data quality metrics via standardized reports. This real-time, centralized surveillance offers focused data oversight activities on risks related to quality, critical subject safety and trial integrity. ERT also offers a plan to prioritize data quality risks and deliver customized site intervention and risk mitigation techniques like site contact or training. This solution provides more meaningful, intelligible data insights for actionable, accurate decision-making to improve data integrity, patient safety, and trial success, as well as save considerable time and cost.

Learn More

Risk-Based Monitoring: Centralized Surveillance of Cardiac Safety Studies

ERT now offers early, proactive trending of site performance on Cardiac Safety data quality metrics via standardized reports. This real-time, centralized surveillance offers focused data oversight activities on risks related to quality, critical subject safety and trial integrity. ERT also offers a plan to prioritize data quality risks and deliver customized site intervention and risk mitigation techniques like site contact or training.

Learn More

Metrics Champion Consortium Best Practices

mcclogo Today’s drug development industry is under increased pressure to improve its research and development performance and strategies by reducing timelines and costs while at the same time dramatically increasing productivity and maintaining quality. Biotechnology and pharmaceutical organizations that achieve efficient clinical trial cycle times attribute their success to maintaining focus on core competencies, prioritizing resource utilization, and outsourcing services. ERT is a member of the Metrics Champion Consortium (MCC), the leading industry association dedicated to the development of standardized performance metrics to improve clinical trials. We collect Key Performance Indicators (KPIs) on a daily, monthly and quarterly basis, enabling us to continue to improve our processes and overall performance. As a member of the MCC Metric Committee, ERT fully supports the collection and reporting of MCC metrics for cardiopulmonary trials.

Metrics Champion Consortium Best Practices

mcclogo ERT is a member of the Metrics Champion Consortium (MCC), the leading industry association dedicated to the development of standardized performance metrics to improve clinical trials. We collect Key Performance Indicators (KPIs) on a daily, monthly and quarterly basis, enabling us to continue to improve our processes and overall performance. As a member of the MCC Metric Committee, ERT fully supports the collection and reporting of MCC metrics for cardiopulmonary trials.

Our Cardiac Safety MCC Metrics Performance

  • Percentage of on-time ECG equipment shipments to sites: 100%
  • Percentage of on-time, accepted ECG file transfers: 100%
  • Percentage of ECG core lab audit/assessment findings closed within agreed timelines: 100%
  • Percentage of ECGs reported to Investigator Sites within agreed turnaround time: 99.6%

Patient Wearables & Other Trial Innovations of Tomorrow

When will the 2-lead ECG be ready for use in clinical trials? How will the BYOD (bring your own device) come into play in cardiac safety? How have changing regulatory conditions impacted the services that CPUs will be required to deliver in the future? ERT maintains close contact with regulators, participates in regulatory and industry leadership groups, and even supports trials sponsored by regulators to push the science and best practices forward as they emerge. With over 20% of annual revenue rededicated into our research and development, ERT partners with all stakeholders to chart the future trends of cardiac safety today.

Patient Wearables & Other Trial Innovations of Tomorrow

ERT maintains close contact with regulators, participates in regulatory and industry leadership groups, and even supports trials sponsored by regulators to push the science and best practices forward as they emerge. With over 20% of annual revenue rededicated into our research and development, ERT partners with all stakeholders to chart the future trends of cardiac safety today.

Want to Influence the Future of Cardiac Safety in Clinical Trials?