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.


500+
cardiac safety drug approvals
9000+
cardiac safety trials
3600+
early-phase studies supported
5400+
late-phase studies supported
200K+
sites total
2M+
cardiac safety patients

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.


SAVE MILLIONS IN DEVELOPMENT AND ENHANCE THE VALUE OF YOUR COMPOUND

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 QUALITY OUTCOMES WITH INPUT FROM INDUSTRY EXPERTS

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.


PROTECT AGAINST THE POSSIBILITY OF FALSE-NEGATIVE RESULTS

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.

ALL YOUR DATA IN ONE PLACE

Leverage our critical, centralized expertise for late-phase global studies with SafePatient ECG. Increase certainty and gain anticipatory oversight with real-time access to centralized clinical and operational study data. Access your data in multiple formats and export, as needed, with two-way integration with external systems.


HARNESS THE POWER OF CENTRALIZATION

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.


DON’T TAKE CHANCES, CHOOSE PATIENT SAFETY

ENSURE QUICK ENROLLMENT DECISIONS

Ensure your late-phase cardiac safety study has the right patients the first time, every time by opting for Rapid QT, 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.


ENSURE PATIENT SAFETY, MAKE ACCURATE ENROLLMENT DECISIONS

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.


SCIENTIFIC EXPERTISE COMBINED WIth ADVANCED TECHNOLOGY

ANALYZE 10x MORE DATA

Secure high-quality, precise ECG data through extensive site training and testing with our exclusive Site Certification Program. 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.


RELY ON 30+ CERTIFIED SITES FOR INCREASED PRECISION AND QUALITY

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.


ENSURE HIGH-QUALITY, PRECISE ECG DATA WITH ERT CERTIFIED SITES

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 9,000+ cardiac safety studies, including more than 3,600+ early-phase and over 5,400+ 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.


UNMATCHED 24/7/365 SERVICE AND 98% OVERALL SATISFACTION

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.


LEVERAGE TOOLS, STRATEGIES & SOLUTIONS THAT BLEND THE BEST OF TECHNOLOGY & MEDICAL EXPERTISE

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.


UNMATCHED 24/7/365 SERVICE AND 98% OVERALL SATISFACTION

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.

 


QUALITY, LONG-TERM ECG MEASUREMENTS FROM THE COMFORT OF 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.


AMBULATORY BLOOD PRESSURE MONITORING FROM THE COMFORT OF HOME

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.


UNMATCHED 24/7/365 SERVICE AND 98% OVERALL SATISFACTION

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.

ADDITIONAL INSIGHTS

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.