Prioritizing patient safety, reduced timelines, and high-quality data
Whether you are a biotech conducting your first Phase I study or a seasoned CRO performing post-market surveillance studies, our team of dedicated experts deliver credible, compliant, and high-quality data you can be certain of.
Our team has supported over 13,800 trials globally to:
- Improve patient safety and enrollment
- Increase data access leading to reduced timelines
- Deliver scientific-grade data to reduce variability
- Ensure devices are delivered on-time globally to avoid delays
Cardiac safety is the #1 reason for drug development failure and post-market recalls
Regardless of your therapeutic target, centralized analysis of your ECG and blood pressure data delivers highly precise results to ensure throughout understanding of the safety profile. This information, backed by our team of experts, helps you prioritize your pipeline and ensure regulatory compliance, saving you time and money.
Available solutions
Arrhythmia Analysis
Collect continuous ECG data with certainty in site-based or decentralized clinical trials with our flexible technology solutions and patient-friendly devices.
Blood Pressure Services
Collect and centrally analyze accurate, consistent, quality blood pressure data from site-based to decentralized trials.
ECG — On-site to DCT and Phase I-IV
Monitor every heartbeat with precision from anywhere to assess safety and efficacy throughout your site-based or decentralized clinical trial.
Phase I/TQT Cardiac Assessment
Fulfill your ICH E14 requirement early, minimize risk and potentially reduce costs throughout your trial by collaborating with our Phase 1 Center of Excellence.
Regulatory Consultation and Statistical Analysis Expertise
Leverage our industry key opinion leaders to understand the complex regulatory landscape while minimizing risk with confidence.
Cardiovascular Imaging
Global comprehensive centralized cardiovascular imaging services ensuring safe and effective treatments.
Advance your decentralized clinical trial with the power of certainty
Global capabilities
With Clario-operated logistics hubs in the US, EU and Japan with the largest, most diverse inventory of validated equipment and 136,000 devices shipped per year.
Clinical and scientific expertise
50 years of clinical trial experience in cardiac endpoints plus a team of cardiologists who bring more than 200 years of clinical expertise powers certainty.
The broadest endpoint technology platform
Our flexible equipment and overread services ensure consistent, quality data, so you can be certain you’re collecting credible data.
Patient-centric experiences
We help power trial continuity patient reminders, coaching and demonstrations to ensure patients experience success.
Proven results earn trust
13,800+
trials supported
580+
new drug approvals
50+
years of science
600+
QT studies
200+
combined years of clinical experience
480+
unique programs
87+
approvals from TQTS alone
230+
sponsors
Cardiac Solutions Science Team
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Todd Rudo, M.D.
Chief Medical Officer
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Borje Darpo, M.D., Ph.D.
Chief Scientific Officer, Cardiac Safety
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Robert Kleiman, M.D.
Chief Science and Regulatory Advisor, Cardiology
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Joel Morganroth, M.D.
Chief Scientific Advisor, Cardiac Safety
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Onglee Weng, M.D.
Vice President, General Manager, Clario-Shanghai and Cardiology
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Jeff Heilbraun, M.S.
Vice President, Medical and Scientific Affairs, Cardiology
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Luc Dekie, Ph.D.
Director Scientific Affairs, Cardiology
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Vickas Patel, M.D., Ph.D.
Vice President and Chief Medical Officer, Cardiology
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Alain Gay, M.D.
Senior Cardiologist and Deputy CMO
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Olga Bokeriya, M.D., Ph.D.
Senior Cardiologist and ECG Core Director
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Fabian Chen, M.D., Ph.D.
VP and Deputy Chief Medical Officer, Cardiology
Increase confidence in site performance with Clario Certified Sites
Clario Certified Sites have completed our Certified Site program to ensure that each study is conducted in an optimal manner and results in the highest quality data. The certification program requires each site to go through an extensive training and testing process. These sites help sponsors reduce study start-up time with well-trained and well-equipped sites.
FAQs
How do you determine which cardiovascular endpoints are most appropriate for my trial?
Your clinical trials need the right expertise to avoid costly delays and bring your products to market efficiently. Our expert science team will examine your protocol and provide a holistic endpoint strategy that supports your trial and best prepares you for the regulatory submission process.
What benefits do centralized cardiac safety solutions provide?
With centralized collection and analysis of cardiac endpoint data, the quality of ECG data contributing to the study analysis is markedly enhanced. Site-based strategies rely on ECG machine algorithm measurements, which are prone to false-positive findings that can prove quite problematic for a development program (false-positive safety signals). With deployment of standardized equipment and centralized core lab analysis of digital ECG data, precision and accuracy are enhanced, and sources of variability and bias are minimized. Centralized cardiac solutions offer additional distinct advantages including:
- More accurate eligibility determinations, ensuring the target population is appropriately enrolled in your study
- Reduced risk of false positive safety findings
- Improved data quality across all trial sites
- Archiving of all ECG data for future analysis or regulatory submission
- Standardized data submission formatting and enhanced data reconciliation
- Ongoing study data access by sponsor, CRO, and site staff through a dedicated study specific portal
Does Clario provide consulting services for decentralized clinical trials?
Yes. Clario’s industry‑leading ECG core lab and team of world‑class cardiac safety experts can provide guidance on the optimal clinical development strategy to meet your program objectives. Solutions offered to support both decentralized or hybrid clinical studies include home ECG, home blood pressure, and remote arrhythmia monitoring. Our consultants can advise on how to most effectively incorporate these elements into a study protocol to ensure high quality, clinically relevant data is captured.
How do we ensure consistent data across global sites?
At Clario, we leverage standardized protocols, centralized training, and centralized data collection and review to minimize site-to-site variability. This ensures your trials produce accurate and consistent data to help you make informed decisions and meet regulatory guidelines. Depending on the study phase and cardiac endpoints, Clario provisions the study sites with standardized ECG and BP collection technology, further enhancing the consistency and integrity of study data at the point of collection.
Speak with one of our experts to learn more
Our team of clinical trial cardiac safety experts are always available to address questions about our cardiac solutions. Submit your contact information and we’ll be in touch shortly.