RELY ON OUR EXPERTISE TO PROVE CARDIAC SAFETY
Cardiac safety concerns are among the leading reasons that promising drugs are delayed or abandoned in development and not brought to market. Safety issues coupled with a complex regulatory landscape mean you need expert guidance to minimize risks and bring clinical treatments to market faster – and with confidence.
OUR EXPERIENCE DRIVES A BETTER EXPERIENCE FOR YOU
As the market leader in cardiac safety, our goal is to deliver a customer experience that is easy, hassle-free and flexible to what you need. Empower your studies with rapid configuration and analysis, quality-driven trial visibility and additional endpoints integrated into ERT EXPERT®, our proprietary technology platform.
ACCELERATE TIMELINES AND OVERCOME OBSTACLES
We help you accelerate timelines and overcome obstacles – delivering on time and on budget, every time. Position your trial for success by collaborating with our Phase I Center of Excellence to improve clinical trial protocols, increase data accuracy and mitigate risk in cardiac safety studies.
PREPARE FOR THE UNEXPECTED WITH ADVANCED TECHNOLOGY
We’re prepared for the unexpected – and ready to guide you with confidence. Apply our innovative solutions and advanced technology to better manage trial complexities and execute studies without compromising regulatory standards.
GAIN CONFIDENCE THROUGH INTEGRATED SOLUTIONS
Instill confidence in your ECG data by integrating and centralizing cardiac data collection and analyses. We help you determine the best device or integrated solution for multiple endpoints based on your protocol and sites.
MINIMIZE RISK AND MAKE SMART DECISIONS WITH EXPERT PRECISION QT
When every millisecond of precision counts, confidently navigate unexpected issues throughout your early-phase trial to close out on time and on budget with our Expert Precision QT (EPQT) approach.
MINIMIZE RISK EARLY AND SAVE RESOURCES
Research shows that 90% of compounds fail to make it past Phase 1. Save time and resources with early insights and improved enrollment via our EPQT approach.
- Save precious time and resources with precise early-phase QT assessments that can lead to a Thorough QT (TQT) waiver
- Improve pipeline prioritization and out-licensing valuation by leveraging early insight into actionable QT data
- Improve enrollment with relaxed QT inclusion criteria from earlier QT assessments
GET CONFIDENCE WITH SCIENCE AND EXPERTISE
Leverage our unparalleled scientific, technology and operational expertise to guide you from protocol through final report. Our proven track record and delivery excellence provide confidence in your results – from small studies to the largest and most complex global trials.
- Tools that blend the best of technology and medical expertise for optimal quality and precision
- Over 3,600 early-phase trials completed and more Phase 1 QT experience than any ECG lab in the world
- Easy and hassle-free studies that stay on time, on budget and can flex to your needs
ANTICIPATORY OVERSIGHT WITH PRECISION
Built and scientifically validated over many years, our proprietary methodology leads to critical precision improvement. Eliminate risk and drive more accurate QT measurements early in your trial’s timeline by implementing this methodology.
- Ensure reliability of data from every study with our Method Bias Sensitivity (MBS) analysis
- Reduce the need for TQT studies in later stages of clinical development with the promise of high data accuracy and precision
- Peer-reviewed publications and a seminal industry study prove benefits of methodology
CRITICAL, CENTRALIZED EXPERTISE FOR GLOBAL STUDIES WITH SAFEPATIENT ECG
Don’t just check a box. Use your clinical data to make critical decisions in late-phase studies with our SafePatient ECG solution.
MINIMIZE RISK IN COMPLEX GLOBAL TRIALS WITH INNOVATIVE SOLUTIONS
Reduce risk and manage the complexities of global studies by communicating closely with sites throughout the lifetime of your study.
- Rely on decades of insight into global regulatory and site expectations
- Collaborate with employees throughout the world, enabling a local touch to global sites and studies
- Navigate complexities with failsafe global logistics
GAIN ANTICIPATORY OVERSIGHT WITH CENTRALIZATION
Choose from the largest inventory of validated equipment and analysis options on the market. Rely on our global footprint and team of dedicated cardiologists and specialists that offer unmatched 24/7/365 customer care and 98% overall satisfaction.
- Minimize risk of unreliable site ECG devices, which can lead to poor inclusion/exclusion decisions, danger for patients and misleading data
- Benefit from a dedicated team focused on studying ECGs, resulting in better site training, fewer queries and no missing data
- Save time when managing closeout or the unexpected by centralizing your data
THE REAL ADVANTAGES OF CENTRALIZATION
INCREASE CONFIDENCE WITH REAL-TIME ACCESS TO DATA
Practical and effective late-phase approaches ready to go for your study. Real-time analytics, centralized data and integrated solutions provide immediate visibility to the highest-quality data.
- Real-time access to clinical and operational study data for insight and efficiency
- Integration of ECG data with other study data
- Early visibility of study progress and issues
COLLECT ACCURATE, RELIABLE, LONG-TERM CARDIAC SAFETY DATA FROM HOME
Long-term cardiac safety data can be difficult to achieve without the right equipment. Take advantage of the largest selection of centralized data storage and standardized, validated equipment that can be best suited to your protocol.
HOLTER ECG COLLECTION
Long-term ECG measurements can be achieved using ambulatory Holter devices at home.
- Standardized Holter ECG collection devices provide identical algorithms and transmission to a central database
- For easy, near real-time data collection and analysis, integrate long-term ECG data with data from ambulatory Holter devices
- Foresee and minimize risks with near real-time visibility into ECG data, integrated with other eClinical data
Learn how you can achieve long-term ECG measurements using ambulatory Holter devices at home.
STANDARDIZED BLOOD PRESSURE DATA COLLECTION
Our ambulatory blood pressure monitoring (ABPM) technology uses the Ambulo™ 2400 device as an automatic, non-invasive device to measure blood pressure over an extended period of time, typically 24 hours.
- Standardize and centralize your home-based blood pressure data collection
- Validated for both adult and pediatric use, transmits blood pressure data directly to our centralized database from the site
- Reinforces protocol compliance, improves data quality, reduces investigator workload and improves the overall user experience
- Measure systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate and sleep cycles, both day and night
TAKE A CLOSER LOOK
BROCHURE: CARDIAC SAFETY OVERVIEW
Check out our integrated cardiac safety solutions.
BROCHURE: CARDIAC SAFETY CONSULTING
Learn more about the professional services our cardiac safety team provides.
WHITE PAPER: THE EXPERT PRECISION QT APPROACH (EPQT)
See how our EPQT approach drives earlier assessments of cardiac safety and supports regulatory change
ERT Launches Phase I Site Certification Program to Improve Efficiencies in Clinical Development
Certified sites enable drug developers to make go/no-go decisions faster and more cost effectively using highly precise ECG data.
TALK TO ONE OF OUR CARDIAC SAFETY SPECIALISTS
Our team of experts is always available to provide consultation on your compound’s cardiac safety and the best, most cost-effective path forward to approval. Submit your contact information, and we’ll be in touch to schedule a meeting.