SMART Submit is a clinical research image processing software designed to streamline the submission of DICOM images for clinical trials. It employs advanced AI technology and over 150 rules to ensure patient privacy, reduce query rates, and enhance image quality. The software offers a user-friendly, browser-based interface for easy image uploads from anywhere in the world, without requiring additional hardware or software installation. SMART Submit's proprietary automated de-identification system is 48 times more effective at removing patient health information (PHI) than other DICOM transport solutions. It also provides efficient quality control checks, custom trial-specific acceptance criteria, and 24/7 multilingual customer support. The platform allows for secure storage and sharing of 21 CFR Part 11 and EU GDPR-compliant images, making it an invaluable tool for clinical trial projects and audits.

Clario's Precision Motion solution offers advanced wearable sensor technology for capturing digital endpoints in clinical trials. The Opal V2C System provides comprehensive movement tests across four core domains: gait, balance, additional mobility, and actigraphy. This technology enables sponsors to quantify richer insights, delivering meaningful clinical outcomes and transforming patients' lives through better evidence for gait, balance, and mobility tests. The system is validated for various indications, including Parkinson's Disease, Multiple Sclerosis, and Spinocerebellar Ataxia. It offers real-time data capture, pre-configured standard assessments, and analytics through the Mobility Lab software platform. With a decade of research backing and over 700 peer-reviewed scientific publications, Clario's Precision Motion solution stands at the forefront of human movement evaluation and patient functional mobility assessment in clinical trials.

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 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 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 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 medical imaging platform offers a comprehensive suite of imaging modalities for research and clinical trials. The platform encompasses a wide range of advanced imaging techniques, including Computerized Tomography (CT), Dual-energy X-ray absorptiometry (DXA), Endoscopy, Medical photography, Magnetic Resonance Imaging (MRI), Molecular Imaging, Optical Coherence Tomography (OCT), Ultrasound, and Radiography. Each modality provides unique capabilities for visualizing and analyzing different aspects of the human body, from bones and soft tissues to molecular-level processes. These imaging technologies enable detailed examination of internal structures, disease progression, and treatment outcomes, supporting various medical specialties and research fields. Clario's platform integrates these diverse imaging modalities to offer comprehensive solutions for medical professionals and researchers, facilitating accurate diagnosis, treatment planning, and scientific investigation across a broad spectrum of medical conditions and research areas.

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.

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's Image Workflow is a cloud-based medical image analysis software platform designed to optimize clinical trial image review processes. It provides a centralized approach to manage datasets, offering custom user workflows for image viewing, streamlined processes, and automated reports. The platform ensures adherence to trial timelines with complete transparency into every step of the image review process, helping identify potential bottlenecks. Key features include custom automated workflows, tracking capabilities, stakeholder management, efficiency improvements, reviewer safety measures, simplified reporting, and performance metric viewing. The system enforces compliance with key data integrity and patient privacy regulations, reduces costs by automating image coordinator workload, and avoids bottlenecks through process transparency. It also offers advanced workflow optimization features and secure, compliant image storage and sharing capabilities.

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 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.

Clario Source Document Manager (SDM) is a comprehensive, web-based application designed to revolutionize the management and organization of source documents for clinical trials. This secure platform enables the collection, de-identification, translation, and organization of source documents in a centralized location, accessible worldwide. SDM offers a user-friendly interface available in multiple languages, ensuring ease of use for global research sites. The system incorporates AI-based Protected Health Information (PHI) detection and redaction capabilities to maintain compliance with 21 CFR Part 11 and EU GDPR regulations. With features like structured data collection, language translation, complete audit trails, and query management, SDM streamlines the entire source document lifecycle. It minimizes workload for research sites and trial management teams while providing 24/7 customer support. SDM is an essential tool for efficient, compliant, and secure clinical trial document management.

Clario's Precision Motion Scientific Consulting Services offer expert guidance for optimizing digital mobility endpoints in clinical trials. The service provides tailored advice to accelerate trial timelines, offering a range of consulting options from protocol development to advanced data analysis. Led by Dr. Sowalsky, the team includes renowned experts in neuromechanics, kinesiology, and data science. They assist in study design, endpoint selection, data interpretation, and custom algorithm development. The service utilizes the Opal V2C system for precise motion measurement, applicable to various neurological and movement disorders. With over 500 scientific publications supporting their technology, Clario's consulting services aim to generate rich evidence throughout the study lifecycle, enhancing the quality and efficiency of clinical trials focused on mobility and movement disorders.

Clario's Clinical Trial Imaging Platform is a secure, streamlined solution for accurate results in clinical trials of any complexity. It leverages in-house medical expertise and proprietary imaging systems to design customized workflows and analysis. The platform eliminates extra costs and time associated with third-party systems by utilizing dedicated engineering teams. With over 30 physicians and 35 scientists specializing in medical and clinical trial imaging, Clario offers unparalleled expertise. The platform incorporates AI for faster, accurate results and features automatic quality control processes that significantly reduce common imaging issues. It also minimizes inter-reader variability and increases accuracy by using AI as an additional set of eyes on every image read. The platform's bespoke workflows and image analysis functions are designed to reflect the complexity of specific protocols, offering flexibility and efficiency in clinical trial imaging.

Clario offers comprehensive medical imaging solutions for clinical trials, combining advanced technology with expert analysis. Their services span the entire trial lifecycle, from protocol design to post-trial assessments, ensuring secure image transfer, quality control, and independent review. With over 30 years of experience, Clario boasts a global network of medical experts across various specialties, supporting trials in more than 70 countries. Their SMART Technology Suite facilitates streamlined image submission and analysis, complying with data privacy regulations. Clario's expertise covers 20+ therapeutic areas and 25+ imaging modalities, backed by 70+ in-house medical and scientific personnel and a network of 450+ readers. Their long-standing relationships with regulatory agencies like FDA and EMA further strengthen their position in the field of clinical trial imaging.

The Opal V2R is a research-grade wearable sensor designed for capturing precise motion data in research studies. It offers high sampling rates, raw data access, and compatibility with various software solutions. The sensor can stream data to Java, Python, and C, sync with other systems, and operate for up to 12 hours at 128Hz. It includes a gyroscope, accelerometer, magnetometer, and barometer. Researchers can choose from three software solutions: Motion Studio for raw data analysis, Mobility Lab for gait and balance assessment, and Moveo Explorer for full-body kinematics. The Opal V2R system is intended for research use only and is not suitable for clinical trials. It is powered by APDM technology and has been used by over 1,000 researchers, featuring in more than 700 peer-reviewed publications.

Early Precision QT (EPQT) is a cutting-edge cardiac assessment solution for Phase I clinical trials, offering precise and cost-effective QT assessments. This innovative approach enables earlier, more accurate cardiac safety evaluations, potentially qualifying for a TQT waiver. EPQT has been clinically proven to provide reliable cardiac safety information typically derived from dedicated TQT studies. It ensures compliance with ICH E14 Regulation while offering a comprehensive range of support from study design to submission. Clario, the provider of EPQT, has supported 70% of all new drug approvals from 2019-2020, demonstrating its expertise in the field. The solution is designed to help researchers understand QT and other ECG effects of new drugs, obtain reliable data earlier in development, and navigate unexpected issues throughout trials, all while partnering with well-trained Clario Certified Sites for efficient study startup and quality data collection.

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.