Cardiac safety is the #1 reason for drug failures & recalls
The proper assessment and reporting of cardiac safety data is essential. Our goal is always to improve patient safety, minimize timelines and deliver high-quality data. Clario supports your entire study cycle from Phase I to Phase IV in all therapeutic areas. With 50 years of experience, Clario has mastered collecting the reliable evidence needed to bring new drugs and therapies to market. Learn how our services help you effectively plan, expertly design, efficiently implement and successfully report on the cardiac safety of your drug.
Proven results earn trust
early phase cardiac services
cardiac analysis & storage solutions
statistical & expert reporting
New drug approvals
Simplified solutions to achieve complex goals
Study design and consultative services
Our in-house, cardiac safety consultants optimize clinical trial protocol design, ensure data accuracy and reduce portfolio risks. They have worked with regulatory authorities for decades and have a thorough understanding of what methodologies and processes should be employed to ensure quality outcomes, and as a result, can guide drug development through cardiac safety regulatory requirements.
Our consulting services include:
- Expert protocol development and study design
- Statistical analysis, including concentration QTc analysis plans
- Expert summary reports for inclusion in the Clinical Study Report
- Regulatory guidance and support
Centralized ECG collection drives optimal enrollment decisions, increases patient safety and speeds trials. Clario is a leading provider of ECG services, with 50 years experience designing and conducting successful studies. We offer a range of options tailored to your compound and to the ever-changing requirements of regulatory authorities.
- Relying on site local ECG collection causes inconsistency and poor quality data.
- Consistent equipment and analysis methodology specifically designed for clinical trials equates to high quality, clean, consistent, digital ECG data, delivered centrally to the client.
- Whether you are looking for a way to virtualize your clinical trial, or an alternative to traditional TTM collection, ERT’s Home ECG is the solution.
- Simple easy-to-use design and is fully integrated with Clario’s platform
- Allows for clinical-trial-quality centralized ECG reads that are self-administered by the patient at home
- Clario offers flexible technology to support patient or traveling nurse collection models with all the same benefits of a traditional site-based ECG
Quality QT/QTc data is imperative in today’s competitive R&D market. We know. Clario supported 70% of all new drug approvals from 2019-2020. Clario offers a full range of support — from study design through submission — for formal Thorough QT studies and for assessing QT safety in clinical trials for which a traditional TQT study is not feasible.
- Help you understand QT and other ECG effects of a new drug and ensure compliance with IHC E14 Regulation
- Obtaining reliable, more precise data earlier in development using clinically proven proprietary Early Precision QT methodology. Option for Collect, Clean and Store. Clario Certified Sites allow for fast startups and highly trained staff.
- Confidently navigate unexpected issues throughout your trial by collaborating with our Phase 1 Center of Excellence and working with highly-trained and qualified sites.
- Leveraging our deep arrhythmia knowledge combined with more patient friendly devices, Clario provides global logistics and clinical trial quality data
- Drugs with increased risk of cardiac arrhythmias require in continuous ECG holter to produced 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
- Regulators are concerned about drugs that produce even small increases in blood pressure. Unlike typical vital sign collection, it is important to use devices and standardized workflows that reduce variability and control factors that can cause inaccurate reporting, thus allowing one to exclude a small drug induced blood pressure change.
- Clario provides flexible options that enforce best practices to ensure valid data — by reducing variability and increasing patient compliance — for insight into both hypertensive and hypotensive effects.
Ambulatory Blood Pressure (ABPM)
Regulators expect ABPM to evaluate the blood pressure effects of new drugs intended for chronic use. Our training program focuses on patient nuances and good patient coaching to improve compliance. Our site application provides immediate success or fail feedback and our portal displays quality analytics to help sites and sponsors track and mitigate patient compliance.
Clinic Blood Pressure (CBP)
Standardized automated device for blood pressure collection during clinic visit. Needed to evaluate drugs intended for short-term use. Clario specialized devices and unique application automate a “Rest Period” to calm the patient, reducing the White Coat effect, automate replicate measurements to reduce variability and report meaningful blood pressure data.
Home Blood Pressure (HBP)
Patient-administered blood pressure collection device with integrated patient diary. Remote blood pressure collection increases the frequency of data collection for better, more longitudinal safety assessment. Clario easy-to-use monitor and tailored application with built-in workflow ensure the patient follows instructions for accurate data collection from their home, and then sends real-time patient data and compliance feedback for immediate investigator review. Superior to other Home BP collection options, Clario solution secures data capture and ensures higher quality data for confident decision making.
Learn more or speak with one our our experts
Our team of experts is always available to address any questions you may have about our cardiac safety solutions. Submit your contact information and we’ll be in touch shortly.