Cardiac safety concerns are among the leading reasons that promising drugs are delayed or abandoned. We offer a range of options tailored to your compound, site locations and ever-changing regulatory requirements.
Product detail
Patch Arrhythmia
- Leveraging our deep Holter arrhythmia knowledge combined with more patient-friendly devices, Clario provides global logistics and clinical trial quality data. We have flexible options for recording durations up to 14 days and offer wire-free single and dual channel recording options.
Holter Arrhythmia
- Continuous 12 lead ECG Holter solution to produce detailed data for 24-48hr increments
- Over 40 years of experience in Holter arrhythmia analysis enables Clario to provide the most consistent, reliable arrhythmia data
Related solutions
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.
FAQs
Does Clario provide continuous at-home Arrythmia monitoring solutions?
Yes. Our patch arrythmia devices are easily worn continuously for up to 14 days and provide high precision and accurate long-term arrythmia data.
Which arrhythmia endpoints might be relevant for my trial?
Commonly used endpoints include heart rate trending, atrial arrhythmia, atrial fibrillation (AF), ventricular tachyarrhythmia, bradyarrhythmia detection, duration and episode counts, along with ectopic beat detection and counts. Selection depends on the targeted indication, established and potential safety risks, and regulatory expectations.
Clario’s team of experts will guide you through selecting the right arrhythmia endpoints for your study protocol and deploy leading solutions to gather the endpoint data you need.
What monitoring technologies are acceptable for regulatory submissions?
Cardiac monitoring technologies will vary from study to study. Clario matches your study and program regulatory objectives to the optimal solutions to support endpoint data collection. This may include standard 12-lead ECG, Holter monitoring, patch monitoring,
and remote ECG technologies. Health authorities expect devices to be approved for clinical trial use and used under a standardized protocol, both central to Clario’s solutions.
How long should patients be monitored to capture events?
Monitoring duration depends on the arrhythmia type and study objectives. For atrial fibrillation, continuous or extended monitoring provides higher sensitivity, while 24–48 hour Holter monitoring may suffice for other safety endpoints or ectopy assessments.
Do arrhythmia endpoints require independent adjudication?
Often yes, especially for endpoint-driven trials. Independent expert or core lab review is expected to confirm arrhythmia type, duration, and clinical relevance. Clario offers a team of experts and a centralized, cloud-based clinical adjudication platform that support adjudication services for your clinical trial.
Learn more or speak with one our experts
Our team of clinical trial cardiac safety experts is always available to address any questions you may have about our cardiac solutions. Submit your contact information and we’ll be in touch shortly.