For Clario, safety spans cardiac, respiratory, precision motion monitoring (via wearables and digital biomarkers) and pharmacovigilance. Rigor in these areas — and many more areas of our business — sustains patient and client confidence.
It is a rigor that has been refined over more than 50 years, during which Clario has launched more than 19,000 clinical trials in 123 countries, 63% of them Phase 2 and Phase 3 studies. We continue to strive to transform people’s lives, and patient and drug safety drives that aspiration.
Our global regulatory expertise — gained through almost 50 years of experience collecting the reliable evidence needed to bring new drugs and therapies to market, drives our compliance efforts. Our pharmacovigilance program includes both clinical and post-marketing drug safety surveillance.
And our unrelenting focus on drug and device safety is critical to the success of our — and most likely your — business.
Our focus on safety includes:
Cardiac safety is one of the top factors in clinical study success. About 60% of all clinical trials include cardiac safety. Clario’s reputation is built, in part, on its innovations in cardiac safety.
Read more about cardiac safety
- Clario strives to address issues such as false positives or negatives in measurements, or regulatory changes such as the FDA’s encouragement of the use of wearables as a component of patient-focused assessment. Our industry-leading technology helps us improve patient safety by conducting, for example, early phase continuous ECG and late phase discrete ECG.
- We cover all phases and therapeutic areas, leveraging our expertise in sensor technology, precision data collection and consistency in data quality.
- Our record with data precision includes such achievements as >95% accuracy vs. <25% by cardiologists. Our protocol designs, statistical analyses and regulatory expertise is unmatched, as are our best-in-class trial design methods.
- Security and privacy — critical components of safety — are included in our systems and services by design.
Respiratory safety, via technology, testing and even patient-reported outcomes (PRO). Our respiratory safety program focuses on precision by design, on obtaining the highest-quality study data. Clario is fully compliant with the latest ATS / ERS standards to reduce the incidence of implausible data and changes in function associated with suboptimal coaching.
Read more about respiratory safety
- We utilize the leading technology to measure lung function.
- Our knowledge of sites’ respiratory safety history will help with your site selection and feasibility assessments.
- Our software customization and integrated devices exceed industry guidelines.
- We employ timely and effective user training to ensure alignment on objectives and quality standards.
- Central quality review of site data drives reliability.
- Business intelligence helps proactively identify site and patient risks.
- Our expertise spans:
- Asthma trials
- Chronic Obstructive Pulmonary Disease (COPD) trials
- Cystic Fibrosis trials
- Idiopathic Pulmonary Fibrosis (IPF) trials
- Lung safety and disease progression trials
- Spirometry collection integrated with other ERT at-home solutions to keep patients safe and studies on track
Clario drug safety surveillance supports clients in current state and future strategic planning and execution. The physicians and scientists who serve as our pharmacovigilance (PV) subject matter experts (SMEs) become your end-to-end partners. They proactively advise and collaborate in designing and maintaining PV services and systems that are both fit-for-purpose and fit-for-the-future. Pharmacovigilance spans pre-approval clinical studies and post-marketing safety surveillance.
Precision motion monitoring and actigraphy
Precision motion monitoring and actigraphy via wearable devices. Clario’s complete wearable precision motion sensor solution, called OPAL® V2C System, delivers objective, high-frequency data combined with scientifically validated endpoints specific to your patient population. When integrated with Clario’s data capture solutions for, among other areas, cardiac safety, you receive a holistic story about how a disease or therapy impacts patient function.
Read more about Precision Motion Monitoring and Actigraphy
- Opal® adapts to patient needs
- Can be single sensor or multiple sensor.
- Can be worn in different areas of the body to adapt to the way a disease impacts patient movement.
- Provides precise data on patient movement in the clinic or at home. Data on more than 100 objective endpoints reveal the quantity and quality of a patient’s movement over a duration of time.
- Can also be used to measure safety endpoints in all therapeutic areas.
- Opal® measures more than activity level — the domain of many devices available in the marketplace. It collects data on gait, balance, turning, and 100+ other endpoints. However, it can be used alongside those devices and in conjunction with Clario’s other data collection solutions.
- The elements of the Opal® V2C System are:
- Digital Biomarkers — proprietary algorithms
- Mobility Lab® — proprietary motion software and reporting platform
- Mobility Exchange, a cloud-based clinical trial management system
Where do we as a company apply rigor to safety?
We adapt quickly to changing global regulations to meet the needs of sponsors, patients, and regulatory agencies. Our track record of deploying trials in more than 120 countries and running 30 facilities in 8 countries shows the depth of our safety vigilance.
In the area of device manufacturing and logistics, we manufacture more than 20,000 devices a year and ship more than 100,000 devices per year from hubs around the globe. This ensures that the right devices get into the hands of the right patients, sites and sponsors.
Clario’s wearable sensors technology and analytics platform is scientifically unrivaled for capturing digital biomarkers to assess functional mobility. Unlike other providers who simply aggregate data — Clario is a clinical endpoints company. Our industry-leading library has 100+ scientifically validated outcomes across both efficacy and safety for key therapeutic areas.
Finally, we probe for insights from our patients. Guided by the belief that better evidence begins with patients’ voices, we design clinical trials based on issues and lifestyle factors important to them. This improves engagement, safety and compliance, which leads to better evidence.