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Cardiac Safety-ECG Monitoring

Transform your drug development

Custom ECG monitoring and cardiac safety solutions to demonstrate the value and safety of your product and improve your probability of success from clinical through commercial.

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Since 2010, we’ve delivered >1.8M ECGs with >98% delivered within the agreed upon timelines. 

Expedite cardiac safety with a streamlined process

With a powerful combination of high performance ECG monitoring and drug development expertise, we bring together operational excellence, medical expertise and global reach to run superior cardiac safety studies and provide biopharma customers with accurate, actionable insights across the product development continuum.

Reducing investigator burden and delivering high quality data

  • Experience conducting >1300 cardiac safety studies, working with >40,000 sites, across 92 countries since 2006 
  • Our process includes that all ECGs get reviewed by staff cardiologists for the deeper insights and more accurate annotations 
  • More than 99% of ECGs processed were reported within the agreed upon timeline since 2014 
  • Studies are centrally managed by experienced project managers for one, accountable point of contact at all times
  • We are available to you 365 days a year, 7 days a week, and 24 hours a day through our follow-the-sun approach

The result? Operational excellence and predictable delivery

Our comprehensive solutions span from protocol development of first-in-man studies all the way through to ECG analysis in the post-marketing setting.  With a combination of medical expertise, operational excellence, and global reach, we’ve been able to help biopharma, academic and non-profit institutions of all sizes make meaningful decisions about their products through accurate and actionable insights.

Interested in learning more about how our team works to increase probability for predictable delivery and deeper insights? Contact us today at clinical@quintiles.com

Project management and oversight   +

Reliable operational delivery so you can focus on the bigger picture

Our global project managers are located in all major regions, and bring experience managing cardiac safety services projects from clinical through commercial across several therapeutic indications.  We understand that project needs can vary on a protocol-by-protocol basis, and we design our processes to support study-specific needs:
  • You have one point of contact, who is accountable for your project’s success
  • That your study conduct is compliant with procedures and conducted with the highest standards and quality
  • Timely delivery of outputs


Medical review and insights   +

Having a complete and exact picture of your drug’s cardiac safety profile is a critical step for demonstrating safety to global regulatory agencies. 

Our interdisciplinary cardiac safety team includes cardiologists, electrophysiologists, clinical pharmacologists, biostatisticians and experts in PK-PD modeling all assembled to help characterize the cardiac safety profile of your compound through careful analysis and interpretation of the study data. 

We’re here to help provide expert guidance from protocol development, regulatory strategy in support of the ICH E14 guidance, and consulting services for non-traditional engagements. 

At Quintiles cardiac safety, your highly trained medical team thoroughly reviews every ECG so that you have an accurate understanding of your drug’s cardiac profile.  We have developed and implemented scientifically rigorous methods, innovative technology solutions and robust QC-QA processes to enable accuracy and precision of key ECG endpoints in accordance with regulatory requirements.  Our services include:

  • Consulting
  • Protocol development
  • Centralized ECG reads
  • Statistical analysis and expert reporting of cardiac safety data across all phases including Thorough QT studies and intensive-ECG phase I studies.
  • Regulatory submission
Cardiac Safety Operations and Workflow   +

All ECGs are reviewed by a board certified cardiologist on staff at Quintiles.  Learn more about our process for providing you deeper insights into your cardiac safety data:
  • Initial review of ECGs is provided by internal medicine doctors (Cardiology Associates) for robust and accurate analysis. 
  • Cardiology associates undergo structured training in ECG reading as per the American College of Cardiology/American Heart Association guidelines.  
  • They are responsible for the initial placement of fiducials for interval duration measurement. 
  • Cardiology associates are benchmarked for accuracy against expert cardiologists using a unique statistical approach called the z-score. 
  • ECGs with significant findings and/or outlier values undergo an additional intermediate review by an Internist (Postgraduate in internal Medicine with ECG certification) prior to final over-read by the Board-certified Cardiologist. 
  • The analysis workflow’s goal is that all queries/issues are resolved through the review mechanism


Data management solutions   +

High quality data for accurate cardiac safety insights

Consistent and high quality ECG data is a critical part of understanding your product’s cardiac effect.    

Delivering timely, accurate ECG data

We’ve developed our processes around the idea of being able to deliver clean ECG data, in near-real time:
  • Data is reconciled on an ongoing basis: the data management team reviews the data using proprietary technologies and cleans this data prior to each load for optimized efficiency during database lock
  • A Dedicated query team to help take the burden off of the sites by being available 24 hours a day, 7 days a week reducing the volume of reconciliation discrepancies & resource efforts

The power of possibilities

Join forces with Quintiles to change the way you approach cardiac safety at any stage of development.

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