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
Make earlier assessments of cardiac safety to mitigate risk and shorten time-to-market with Expert Precision QT (EPQT) – clinically validated and developed in collaboration with industry-leading cardiac safety experts. EPQT can:
- Ensure that promising drugs are not inappropriately eliminated due to inaccurate cardiac safety data
- Introduce new drugs to the marketplace earlier
- Eliminate unnecessary late stage TQT studies
GET 10X MORE DATA ANALYSIS
Capture high-quality data with the only clinically-validated early-phase methodology, EPQT. Analyze 10 times more data than conventional methods to ensure your data is reliable and precise, every time.
Minimize the risk of data uncertainty in your next early-phase cardiac safety study with Expert Precision QT (EPQT).
BUILD CONFIDENCE IN YOUR STUDY DATA
Waiting until Phase 2 to determine the cardiac safety of your compound increases the risk of losing time and money. Save millions and shorten time-to-market with the only clinically-validated early-phase solution, Expert Precision QT (EPQT).
View this infographic to see how you can minimize risk and make smart decisions with earlier, more precise QT assessments.
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.
HARNESS THE POWER OF CENTRALIZATION
Paper-based studies can put your patients, trials and compounds at risk while compromising data quality, extending timelines and increasing costs. Centralizing your ECG data ensures:
- Improved patient enrollment process
- Real-time access to data throughout the entire study
- Higher quality data with reliable results
- Compliance with regulatory requirements
PROTECT YOUR PATIENTS AND COMPOUNDS
50% of late-phase clinical trials are still putting their patients and compounds at risk by using paper-based methods to collect, store and analyze their cardiac safety data. Reap the rewards of centralization in your next late-phase study with ERT’s SafePatient ECG solution and have confidence in:
- Increased data accuracy
- Reduced risk
- Safer patients
HAVE CONFIDENCE IN REAL-TIME ACCESS TO DATA
By centralizing your cardiac safety data, you have be sure that your data is stored in one place and can be accessed during the duration of the study and for years to come. Centralization offers the following benefits:
- Secure storage for archived data
- Regulatory requirement compliance
- Data converted to correct submission format
Download this case study to see how centralization helped a trial sponsor when the FDA requested archived ECG data years after the study ended.
HIGH QUALITY DATA ASSURED
ERT’s exclusive Site Certification Program secures high-quality, precise, ECG data through extensive site training and testing. Analyze 10 times more data than conventional methods and reduce data variability by partnering with an ERT Certified Site for your next early-phase cardiac safety study.
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.
STANDARDIZED 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
- Centralize long-term ECG data with integration from ambulatory Holter devices for easy, near real-time data collection and analysis
- 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
Learn how to collect accurate, reliable ABPM data with consistent devices and centralized data analysis.
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
ARTICLE: Assessing Cardiac Safety in Phase I
Learn how clinical trial sponsors who conduct QT assessments during Phase I can harness the power of early knowledge to better inform their development decisions while saving considerable time and money.
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.