Clario's arrhythmia analysis solutions provide reliable continuous ECG data collection for clinical trials, offering flexible options for both in-clinic and at-home monitoring. With over 40 years of experience in Holter arrhythmia analysis, Clario delivers consistent and high-quality cardiac safety data to help address one of the leading reasons promising drugs are delayed or abandoned. The company offers two main product options: Patch Arrhythmia, which utilizes patient-friendly devices for up to 14 days of wire-free recording, and Holter Arrhythmia, which provides detailed 24-48 hour continuous 12-lead ECG data. These solutions are tailored to meet specific compound requirements, site locations, and evolving regulatory needs. Clario's expertise in arrhythmia analysis supports pharmaceutical, biotech, and medical device partners in generating robust clinical evidence while ensuring patient safety throughout the drug development process.

Clario's Blood Pressure Services offer comprehensive solutions for clinical trials, addressing regulatory changes and implementing various blood pressure monitoring methods. The portfolio includes Ambulatory Blood Pressure Monitoring (ABPM), Clinic Blood Pressure (CBP) services, and Home Blood Pressure (HBP) services. These solutions cater to different trial needs, from chronic drug use evaluation to short-term assessments, providing flexibility in data collection settings. Clario's approach focuses on patient compliance, data quality, and regulatory alignment, utilizing specialized devices and applications to ensure accurate measurements and reduce variability. The services are designed to meet new FDA draft guidance requirements, assessing drug effects on blood pressure and adding valuable endpoints to clinical trials. Clario's expertise extends to regulatory consultation and statistical analysis, offering a complete package for cardiac assessments in clinical research.

Clario offers comprehensive cardiovascular imaging solutions for clinical trials, supporting a wide range of modalities and indications. Their multidisciplinary team includes scientific experts, board-certified cardiologists, radiologists, and technologists who ensure rigorous study design, image acquisition, and expert central assessment. Clario's services cover various imaging modalities, including cardiac MRI, CT, ultrasound, and echocardiography, with expertise in both cardiovascular and non-cardiovascular indications. They provide robust imaging data through rigorous quality control, site qualification, and ongoing technical support. Clario's regulatory team offers guidance for submissions to FDA, EMA, PMDA, and CFDA. Their experience spans over 300 cardiovascular clinical trials, 30+ cardiovascular indications, and 70+ non-cardiovascular endpoints, supporting 4,000+ sites. Clario's approach ensures high-quality data, limits variability, and enhances the interpretability of clinical trials.

Clario's Clinical Adjudication solution offers a comprehensive platform for managing Clinical Event Committees (CECs) in clinical trials. It combines experienced project management, deep clinical expertise, and an advanced web-based platform to streamline the adjudication process. The solution provides rapid study initiation, expert guidance on charter design, and a centralized repository for all trial-related documents and data. It ensures compliance with regulatory requirements, enhances data quality through AI-powered de-identification, and offers seamless integration with third-party applications. Clario's global network of medical experts covers various therapeutic areas, providing specialized knowledge when needed. The platform also offers full data transparency with visual performance metrics and 24/7 live support. This all-encompassing approach aims to improve the efficiency, accuracy, and quality of clinical trial adjudication processes.

Clario's ECG solution for Phase I through IV clinical trials offers centralized ECG collection to enhance patient safety, optimize enrollment decisions, and accelerate trials. With 50 years of experience, Clario provides customizable options for traditional and home ECG collection, ensuring high-quality data and consistent analysis. The solution supports both site-based and decentralized clinical trials, featuring easy-to-use designs for patient-administered ECGs at home. Clario's approach minimizes risks associated with cardiac safety concerns, a leading cause of drug development delays. The company's expertise extends to related services such as arrhythmia analysis, blood pressure monitoring, Phase I/TQT cardiac assessment, and regulatory consultation. By leveraging Clario's ECG services, sponsors can navigate complex regulatory landscapes and execute trials efficiently in challenging environments.

Clario's eCOA solutions provide comprehensive electronic clinical outcome assessment capabilities for clinical trials of all sizes. The platform offers rapid setup and deployment through simplified design, greater configuration options, faster translations, and pre-built validated assessment libraries. With 25 years of experience in decentralized and hybrid trials across over 120 countries and 100 languages, Clario's eCOA services include flexible technology options like bring-your-own-device (BYOD), web-based, or provisioned devices. The configurable platform adapts to specific trial needs and integrates with connected devices to capture various endpoints. Key features include accessibility enhancements like zoom and dark mode, flexible device modalities, and scientific guidance from therapeutic area experts. Clario's eCOA solutions aim to streamline the clinical trial process, improve data quality, and enhance the participant experience while meeting regulatory requirements.

eCOA Live is a decentralized clinical trial solution that allows patients to complete electronic Patient-Reported Outcomes (ePROs) from home, mimicking the in-clinic experience. This innovative approach offers patients flexibility in how and where they participate in clinical trials, enhancing patient-centricity. Unlike traditional methods, eCOA Live enables patients to enter responses electronically and privately, minimizing clinician bias and resulting in more accurate, honest data. The system works by allowing patients and clinicians to log in from different locations, with the clinician initiating the assessment and passing control to the patient for private completion. eCOA Live complies with data privacy regulations, including HIPAA, GDPR, and 21 CFR Part 11, ensuring data security. It can be combined with telehealth video visits for enhanced decentralized solutions, offering face-to-face interactions between patients and clinicians.

eCOA Multimedia is a powerful solution for clinical trials that combines electronic Clinical Outcome Assessment (eCOA) with photo and audio capture capabilities. This innovative tool allows researchers to evaluate drug efficacy more accurately using a single secure device. It enables the compilation of a holistic view of a patient's condition without additional effort, facilitates accurate tracking and monitoring of progress over time, improves compliance through the use of a single device, and achieves standardized, high-quality images and audio recordings. The system integrates seamlessly into the normal eCOA workflow, providing a straightforward experience for patients and researchers alike. With features like at-home photo capture, eCOA Multimedia enhances patient safety, allows for visual progress tracking, and improves overall compliance in clinical trials.

Clario's Image Redact AI is a medical imaging solution designed to enhance patient privacy, ensure compliance, and streamline clinical trial research. This advanced software uses proprietary AI functionality to de-identify medical images, reducing the risk of data breaches and potential fines. The system offers 21 CFR Part 11 and EU GDPR compliance, robust security measures, and 24/7 multilingual customer support. It enables easy access and review of secure videos, photos, and PDFs on any device, saving time and reducing costs for clinical trial projects. The software includes features like pre-submission image screening, expedited processing for high-priority reviews, and batch importing capabilities. Clario's team can also develop trial-specific AI models to automate data screening and de-identification, tailoring the solution to meet specific research needs.

Clario's Medical Image Storage Repository is a secure, web-based cloud storage system designed for clinical trial projects and audits. It offers tools to store, access, and share medical images and documents globally, ensuring 21 CFR Part 11 and EU GDPR compliance. The platform supports various file formats, including DICOM, PDF, photos, videos, and ECGs. Key features include easy image submission, de-identification and quality assurance processes, and a global cloud network for secure storage. The system allows for easy uploading, searching, viewing, and authorized downloading of de-identified DICOM images. With long-term retention capabilities, accessible from any device, and requiring no additional hardware or software installation, Clario's Image Repository streamlines the management of medical images for clinical trials and research purposes.