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. Position your trial for success with our cardiac safety solutions, which provide you with the highest quality patient data on time – and in real-time.
MONITOR EVERY HEARTBEAT WITH PRECISION
Be confident in your data with centralized cardiac safety solutions. With all your data in one place, you can save time and navigate the unexpected. Empower your studies with rapid configuration and analysis, real-time trial visibility and additional endpoints integrated into ERT EXPERT®, our proprietary technology platform.
EMPOWER YOUR STUDIES
Empower your studies with standard assessments, high-quality data and centralized monitoring. Position your trial for success with our cardiac safety solutions, which provide you with the highest quality patient data on time — and in real-time.
INCREASE PATIENT SAFETY
Safety issues coupled with a complex regulatory landscape mean you need expert guidance to minimize risks and bring clinical treatments to market faster. Navigate complexities and increase patient safety by centralizing cardiac data collection and analyses.
HAVE CONFIDENCE IN YOUR CARDIAC SAFETY STRATEGY
Gain confidence in your ECG data through our integrated cardiac safety solutions. Our team of scientists and clinicians can help determine the best strategy for analyzing cardiac safety and the best devices to collect high-quality data.
STANDARDIZED AND CENTRALIZED CARDIAC SAFETY ASSESSMENTS IN EARLY-PHASE TRIALS
When every millisecond of precision counts, confidently navigate cardiac safety assessments in your early-phase trial to support protocol compliance, improve data quality, reduce investigator workload and shorten time-to-market.
MINIMIZE RISK AND MAKE SMART DECISIONS
Build confidence in your study data and eliminate risk by driving earlier, more precise and cost-effective QT assessments with Expert Precision QT (EPQT). You could save millions in development costs and potentially qualify for a TQT waiver by getting more granular insights in the initial stage of your development pipeline.
CONSULTING THAT DELIVERS
Optimize your early-phase clinical trial protocol design, ensure data accuracy and reduce portfolio risks by accessing the expertise of our in-house, world-renowned cardiac safety consultants.
ENSURE THERE IS NO BIAS IN STUDY RESULTS
Ensure you can collect QT data from a Phase 1 study and have confidence in your data reliability with Method Bias Sensitivity (MBS) analysis, an advanced quality metric. MBS provides more certainty to regulators and sponsors that the ECG core lab’s measurement methodology does not introduce relevant bias into your results, protecting against the possibility of a false-negative result.
HAVE CONFIDENCE IN LATE-PHASE STUDY RESULTS WITH CENTRALIZED DATA
Relying on site-managed ECG devices introduces variability and can lead to poor patient inclusion and exclusion criteria and enrollment decisions, posing potential danger to study subjects. Instead, increase data accuracy, mitigate risks and protect your patients and compounds by centralizing all your ECG data in one place.
ENSURE QUICK ENROLLMENT DECISIONS
Ensure your late-phase cardiac safety study has the right patients the first time, every time by opting for Rapid ECG, our alert service to analyze screening and other ECGs. As the only central lab to offer this service, you can have confidence that experts will analyze screening and other ECGs in digital format within 4 hours before the inclusion/exclusion decision is made and while the patient is at the site.
REDUCE RISK AND MAXIMIZE PATIENT SAFETY
Don’t put your patients at risk due to incorrect patient inclusion/exclusion decisions. Accurately identify QT intervals to avoid false inclusions, exclusions, continuations and discontinuations in your late-phase study.
HIGH-QUALITY CARDIAC SAFETY DATA ASSURED
Confidently navigate unexpected issues throughout your trial by collaborating with our Phase 1 Center of Excellence and working with highly-trained and qualified sites.
HAVE CONFIDENCE IN YOUR DATA
Collaborate with our Phase 1 QT Center of Excellence to gain actionable and highly reliable information about the cardiac safety profile of your compound at the earliest possible time in the drug development process. Have confidence in your cardiac safety data by teaming with our scientists, clinicians and in-house statisticians who have shaped and driven cardiac safety advancements for the past 25 years.
A COMPETITIVE EDGE FOR YOUR SITE
Ensure proficiency in collecting the highest quality ECG data in Phase 1 studies as an ERT Preferred Site, which are certified sites that have been trained and qualified based on specific criteria. Becoming an ERT Preferred Site can be a competitive advantage, enabling you to attract more trial sponsors, benefit from a full training program and collaborative opportunities and ensure access to our cardiac safety consultants.
INCREASE CONFIDENCE WITH SCIENCE AND EXPERTISE
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. Monitor every heartbeat with precision and ensure safety with ERT Cardiac Safety Consulting Services.
OUR EXPERIENCE DRIVES A BETTER EXPERIENCE FOR YOU
Our global team of cardiac experts and regulatory specialists has managed over 9,900+ cardiac safety studies, including more than 3,700+ early-phase and over 6,100+ late-phase studies. Have confidence in your study results by leveraging our unparalleled scientific, technology and operational expertise to guide you from protocol through final report, from small studies to the largest and most complex global trials.
OPTIMIZE THE QUALITY AND PRECISION OF YOUR CARDIAC SAFETY STUDY DATA
Avoid safety and regulatory issues long before they become critical with strategic protocol and study design for early- and late-phase studies. Our consulting team can also help you determine the best devices and integrated solution and select the best strategy for analyzing cardiac safety.
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
Clinical trial sites will find that ERT’s ABPM technology
- is simple to use: Patients and site staff can easily secure the device, and it is comfortable for extended wear.
- improves patient security by removing protected health information.
- provides immediate results and pass/fail feedback, enabling site staff to coach patients during that office visit.
Learn how to collect accurate, reliable ABPM data with consistent devices and centralized data analysis.
MINIMIZE RISKS AND BRING TREATMENTS TO MARKET FASTER
Leverage our dedicated team of in-house statisticians who deliver data reliability metrics and enable dose escalation and other time-sensitive decisions. Experience better site training, fewer queries and no missing data with your next cardiac safety study.
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.
ARTICLE: ERT INTRODUCES RAPID ECG
Rapid ECG™ delivers reliable, centralized ECG analysis within 4 hours to ensure patient safety and accelerate clinical trial enrollment
BLOG POST: KEEPING CLINICAL TRIAL PATIENTS SAFE: WHY YOU CAN’T RELY ON AUTOMATED ECG MACHINE MEASUREMENTS
Learn why relying entirely on ECG machine QTcF measurements for clinical trial decisions may have critical consequences for trial integrity as well as for patient safety, based on a recently conducted comparison study.
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.