Our experts can assist you in navigating regulatory changes and implementing the right blood pressure monitoring method or methods for your trial, including ambulatory blood pressure monitoring (ABPM), clinic blood pressure services (CBP), and home blood pressure services (HBP).
It’s long been known that high blood pressure can lead to cardiovascular events. Now, regulators are looking for a connection between increases in blood pressure and drug therapy. As a result, new FDA draft guidance advises sponsors to assess a drug’s effect on blood pressure.
Our complete Blood Pressure (BP) Services portfolio meets clinical trial needs by adding additional endpoints and addressing non-clinic-based environments. You have the flexibility to collect patients’ blood pressure in clinic or at home in a traditional, hybrid or decentralized situation.
Ambulatory Blood Pressure (ABPM)
Regulators expect ABPM to evaluate the blood 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, and automated replicate measurements to reduce variability and report meaningful blood pressure data.
Home Blood Pressure (HBP)
Easy-to-use home blood pressure device with integrated smartphone application extends the frequency of data collection for better safety assessment. Clario’s application walks the patient through each step to improve patient confidence and success and then sends real-time data and compliance feedback for immediate investigator review. Superior to other Home BP collection options, Clario’s solution ensures higher quality data for confident decision making.
Collect continuous ECG data with certainty in site-based or decentralized clinical trials with our flexible technology solutions and patient-friendly devices.
ECG — On-site to DCT and Phase I-IV
Monitor every heartbeat with precision from anywhere to ensure safety 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.
Learn more or speak with one our experts
Our team of clinical trial cardiac safety experts are always available to address questions about our cardiac safety solutions. Submit your contact information and we’ll be in touch shortly.