ERT CARDIAC SAFETY

Monitor every heartbeat with precision and ensure safety

RELY ON OUR EXPERTISE TO PROVE CARDIAC SAFETY

Cardiac safety concerns are among the leading  reasons that  promising drugs are halted in development and not brought to market. Put our expertise in ECG, Holter and blood pressure data collection & analysis to work for you.


445
cardiac safety drug approvals
6700+
cardiac safety trials
220+
TQT trials
200K+
sites total
70K+
active sites
2M+
cardiac safety patients

INCREASE TRIAL VISIBILITY THROUGH SEAMLESS DATA INTEGRATION

Ensure patient safety with access to near real-time analytics, centralized surveillance and more monitoring options for the highest quality cardiac data.

CONFIDENCE IN COLLECTION AND ANALYSES
We help you determine the best device or integrated solution for multiple endpoints based on your protocol and sites, then select the best analysis strategy. High standards of quality control are applied at every phase of development.

LEVERAGE EARLY DATA FOR APPROVALS
We have extensive experience in Phase I intense ECG collection and analysis as well as Thorough QT trials. We stay on top of regulatory changes, including the recently added option to use Phase I data to assess the QTc liability of new agents in the ICH E14 guidelines.

MINIMIZE RISK WHILE COLLECTING ECG DATA
Protect patient safety as well as your drug asset so you can move quickly to regulatory approval. We provide standardized devices to all of your sites, train your investigators on collecting quality data and transmit for central analysis. We conduct a series of quality control checks, including 100% cardiology overreads on every ECG.

COLLECT DIAGNOSTIC DATA MORE EFFICIENTLY

Leverage the largest selection of validated cardiac safety devices and our expertise in protocol review and analytic knowledge to enroll targeted patients and collect quality cardiac safety data from sites more efficiently.

PHASE I/TQT

Develop your best plan for Phase I and Thorough QT (TQT) trials:

  • We’ve conducted more than 220 TQT studies
  • Alleviate process burdens with our centralized, integrated solution
  • Optimize your protocol design based on recent ICH E14 changes to replace the costly, standalone TQT study
  • Leverage T-wave morphology for certainty when you uncover a borderline QTc signal
  • Accurately comply with regulations, including formatted xml files and uploading of ECG digital files to the appropriate warehouse
Near real-time data access for timely review and accurate submissions

ECG

Leverage our unrivaled cardiac safety consulting expertise to collect accurate, reliable ECG data:

  • Standardized 12-lead and Holter ECG collection devices provide identical algorithms and transmission to a central database
  • Enroll more patients with accurate ECG machine measurements during screening
  • Foresee and minimize risks with near real-time visibility into ECG data, seamlessly integrated with other eClinical data
  • In eCOA studies with cardiac safety, integrate to boost site efficiency and reduce costs
  • Store clean digital ECG data in the required FDA ECG XML warehouse formatting
Centralized, high-precision ECG measurements

BLOOD PRESSURE

Collect accurate, reliable blood pressure data with consistent processes and centralized data:

  • Consistent training for data collection
  • Standardize and centralize your ambulatory blood pressure monitoring data with the Ambulo™ 2400 device, validated for both adult and pediatric use
  • Improve the user experience by measuring systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate with the easy-to-use Ambulo™ 2400 device
  • Foresee and minimize risks with near real-time visibility into blood pressure data, integrated with other eClinical data
Centralized, reliable blood pressure data

COLLECT LONG-TERM CARDIAC SAFETY DATA FROM HOME

Long-term cardiac safety data can be difficult to achieve without the right equipment. We have the largest selection of centralized data storage and standardized, validated equipment that can be best suited to your protocol.

COLLECT ACCURATE, RELIABLE, LONG-TERM ECG DATA

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 your long-term ECG data with integration from a number of ambulatory Holter devices into our centralized database 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

 

Quality, long-term ECG measurements from the comfort of home

COLLECT ACCURATE, RELIABLE, LONG-TERM BLOOD PRESSURE DATA

Our ambulatory blood pressure monitoring (ABPM) technology utilizes 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 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

Collect accurate ABPM data from the patient’s home

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

WEBINAR: ONE YEAR LATER — THE IMPACT OF ICH E14 REVISIONS ON CARDIAC SAFETY

Learn more about how the recent regulatory change has affected the strategy and execution of cardiac safety studies.

PAPER: USE OF CONCENTRATION-EFFECT MODELLING FOR CARDIAC SAFETY ECG ASSESSMENTS

Get the science behind how to implement the recent ICH E14 regulatory change in your Phase I trials in this peer reviewed paper.