Most clinical trials are now hybrid studies, in which some activities are conducted at sites while others are conducted remotely.
With Trial Anywhere™ solutions, Clario is uniquely equipped to help sponsors collect compliant endpoint data across modalities, geographies, and sources.
Local Clinic or Home Nurse Service
Clario has the deep experience and capabilities to support these more complex hybrid and decentralized clinical trials:
Scientific & domain expertise
- Protocol consulting for quality endpoint device and data collection
- Cross-clinical therapeutic area expertise
- Safety, efficacy and regulatory expertise
Technology innovation & operational excellence
- Experience in device provisioning into >100 countries with regional hubs
- Scalable, secure and robust solutions
- Reporting, trial oversight, business intelligence (BI) and analytics
DCTs have shown that although patients like the convenience of telehealth and other in-home options, they don’t want trial participation to be complex or confusing. Clario can simplify the patient experience, broaden participation and ensure the collection of rich endpoint data during a decentralized clinical trial:
- Online device and solution training
- Live, virtual clinicians to guide through assessments
- Smart reminders and notifications
- Toll-free phone support is available anytime, anywhere
- Multilanguage support
Explore Clario’s portfolio of Trial Anywhere™ solutions
Simplify the patient and investigator experiences to collect accurate, compliant endpoint data.
For any decentralized clinical trial. Anywhere.
Next generation respiratory home monitoring
Collecting pulmonary endpoint data doesn’t need to be difficult, but standards of effective test performance must be met. Clario iSpiro® conducts full spirometry at home, collecting pulmonary endpoints that are increasingly important in clinical research. iSpiro combines the iSpiro App and handheld device with an easy‑to‑use spirometry sensor that meets American Thoracic Society/European Respiratory Society (ATS/ERS) requirements.
iSpiro is designed to both educate the patient and improve the quality of the spirometry data collected:
- Guides patient through the lung function assessment to generate high-quality, reliable data
- Includes easy-to-follow instructional videos and step-by-step instructions by integrating with Clario’s Virtual Visits telehealth technology
- Reviews the patient’s performance to maximize the effort and to ensure data capture meets regulatory requirements
- Provides on-screen test results, quality statements and feedback
The iSpiro App also reduces investigative site burden through a simplified patient-specific setup. QR codes generated through a portal and a quick setup checklist make deployment easy for sites and patients.
Learn more about Clario’s comprehensive Respiratory solutions.
Home blood pressure
Precise data and unrivaled expertise
When your goal is to collect and analyze high-quality blood pressure endpoint data, you need an experienced provider to help minimize errors. An incorrectly applied cuff or a patient not resting fully could impact data quality and consistency. Clario’s blood pressure monitoring solution collects high-quality BP endpoint data while minimizing patient error.
- Provides coaching and demonstrations for how to apply the blood pressure cuff and advise the patient correctly
- Issues helpful reminders to patients during the process
- Automated serial blood pressure inflations and automated interval between inflations to reduce BP variability
- Cardiologists review patient readings to detect any abnormalities in blood pressure data capture
- Prompts the patient to sit quietly for 5 minutes and provide relaxing visualizations
Learn more about Clario’s comprehensive Cardiac Safety solutions.
Drive cardiac safety with rigorous, responsive tools
Inaccurate electrocardiogram (ECG) results based upon algorithmic interpretation or inexperienced reads may produce false-positive/negative results and an inconsistent final data set. Clario’s easy-to-use mobile ECG is integrated with our proprietary platform to enable seamless site management, a patient-friendly experience and timely report availability.
- KardiaMobile 6L integrated with Clario’s platform ensures seamless site management, a patient friendly experience and timely report availability
- Trained cardiac specialists measure ECGs and assess quality
- 100% over-read by Clario’s cardiologists to confirm measurements and provide diagnostic evaluation
- Clario portal allows sites and study teams to monitor quality
Learn more about Clario’s comprehensive Cardiac Safety solutions.
Bring the trial to patients safely and conveniently
Electronic Clinical Outcome Assessments, or eCOA, measure how patients feel or function during clinical trials. By capturing secure clinical data electronically, eCOA avoids the quality and time issues associated with paper diaries, such as illegible answers, transcription errors and inconsistent or conflicting data.
eCOA not only comes in many forms but can be easily integrated with connected devices, wearables or sensors to unlock additional evidence.
- ePRO: Patient-Reported Outcomes. Patients report on their health via questionnaires or assessments. Examples include quality of life or activity outcomes.
- eClinRO: Clinician Reported Outcomes. A clinician reports health outcomes. An example may include a physical examination such as PASI.
- eObsRO: Observer Reported Outcomes. Completed by someone other than the patient or the clinician, such as a caregiver, based on events and behaviors observed.
- ePerfO: Performance Outcomes are measures from specific tasks the patient performs. An example might be performing a timed task of gait, balance or mobility.
Clario’s eCOA brings the trial to your patient, enabling sponsors to deliver at-home, remote and fully virtual clinical trials. Our aim is to make participation convenient and safe while ensuring high-quality, regulatory-compliant data.
Learn more about Clario’s comprehensive eCOA solutions.
A powerful combination of eCOA and photo and audio capture
eCOA Multimedia captures consistent high-quality photos to enhance ePRO data, while mitigating risks and improving patient experience. The solution reduces site visits to keep patients safe. Clinicians track progress visually over time to measure efficacy more accurately. And the common device for both ePRO assessments and photo capture improves patient compliance.
Evaluate drug efficacy more accurately with eCOA Multimedia, using a single source device.
- Compile a more holistic view of a patient’s condition, without any additional effort
- Track and monitor progress more accurately and easily over time
- Improve compliance using a single device
- Achieve standardized, consistent high-quality images and audio recording
Introducing eCOA Multimedia
How it works
eCOA Multimedia is integrated into the normal eCOA workflow, delivering high compliance and a straightforward experience:
- Patient completes their ePRO assessment on a handheld or tablet device
- For questions which require an image, the camera automatically activates along with instructions
- Photo is linked to the patient’s eCOA assessment and submitted automatically and securely to the study database
- Image is processed securely, de-identified and analyzed using Clario’s market-leading Imaging capabilities
Reinventing clinical endpoint measurement
Traditional methods of assessing movement disorders, such as clinical rating scales, are subjective and prone to human bias. And data from activity monitors like Fitbits and the Apple Watch may not accurately capture the differences between patients and controls.
Clario’s complete wearable motion sensor solutions overcome these limitations. When integrated with our data collection solutions for cardiac safety, eCOA, digital patient, imaging or respiratory, whether in-clinic or virtually, Clario precision and passive motion devices provide a holistic story of how disease and therapy impact patient function.
Precision motion monitoring
The objective is to collect consistent high-quality active assessments of functional mobility outcome measures. The Clario solution addresses potential quality risks including patient missing at-site clinical assessments and clinical subjective bias through the following:
- Precision motion monitoring (PerfO) of gait, balance and mobility, delivering high fidelity data of instrumented standardized assessments from remote and/or in-clinic locations
- Pre-configured standard assessments and instrumented tests embedded in software with greater than 140 validated outcome measures
- Precision motion analytics through Clario’s Mobility Lab software platform that are objective, validated, sensitive and reliable
- Capture of meaningful functional mobility endpoints to patients as related to Quality of Life and Activities of Daily Living
- Guided patient coaching through the assessment procedure
- Real-time notification indicating acceptable test performance and data capture
Remote patient monitoring
The objective with Actigraphy is to capture continuous real-world patient activity via remote passive monitoring. Our solution addresses concerns including gaps in evaluable data and subjective recall of activity not reflecting actual experience by:
- Quantifying daily physical activity & sleep to complement Quality of Life and other Patient Reported Outcomes (ePRO) data for any trial
- Combining objective measures on wearables sensors with context and meaning on ePRO for a comprehensive picture
Learn more about Clario’s comprehensive Precision Motion solutions.
Image capture closer to home
Convenience in clinical trials is a must — yet 60% of patients cite distance and travel time as key considerations to participating in life-changing research. Exclusion of any community reduces patient representation, extends trial timelines and incurs additional costs.
With FlexImaging, Clario provides you with access to a network of prequalified, trial-ready, satellite imaging sites within 30 minutes of patients to:
- Reduce patient drop-out, delays and additional costs
- Increase patient access to treatments
- Improve representation within patient populations
Hassle-free site addition
- Clario investigates, qualifies and procures suitable FlexSites that meet GCP standards
- Clario validates protocol compliance and eligibility for individual studies at FlexSites
- Clario handles all billing, accounting and reimbursement to FlexSites for study images
- Clario provides 24/7 customer support
To minimize patient travel time, our initial FlexSites are each within 120 miles of Philadelphia, Boston and Cleveland — providing close-to-home standard-of-care imaging for CT, X-rays and PET/MRI.
Learn more about Clario’s comprehensive Imaging solutions.
Collect. Connect. Engage.
Clario’s Virtual Visit solution supports your move toward decentralized clinical trials (DCTs) by enabling at-home consultations between patients and sites via a simple, secure app or web interface.
Our remote video call technology offers a convenient and simple way for patients to “see” their clinicians from the comfort of their own homes, reducing the need for site visits. Global regulators have warmly embraced decentralized methodologies since the start of the COVID-19 pandemic, and several have issued guidance supporting the use of alternative methods of engagement. DCT tools and methodologies used by our at-home clinical trial management experts generally:
- Enable secure, at-home video consultations between patients and investigative sites
- Improve patient engagement and study continuation
- Simplify patient and investigator participation in clinical trials and post-approval studies
Why use Clario’s eCOA telehealth solution?
Telehealth makes trial participation easier for patients and investigators.
- Fewer site visits and less time spent at the site
- Live meetings with clinicians help maintain face-to-face contact, driving engagement
- Video visits are easy to set up for both patients and sites
Telehealth benefits for site & sponsor
- Get started fast with a solution that is rapid to deploy
- Minimize patient safety risks by arranging on-demand site-patient visits without the need for a site visit
- Confidence in a secure solution that is fully compliant with EU GDPR, HIPAA and 21 CFR Part 11
Alivecor KardiaMobile 6L
Clario’s Virtual Visits works in tandem with a number of our endpoint data generating tools, including ECG devices for Cardiac Safety, iSpiro Respiratory solutions, ePRO assessments and more.
Deliver better evidence. Faster.
Clario’s at home clinical trial management company provides you with the capabilities and expertise required for your next clinical trial — whether it’s decentralized, hybrid or traditional:
- Clinical expertise to optimize study planning, patient monitoring and trial oversight
- Continuous innovation to fuel enhanced patient experience and TA solutions
- Operational excellence to support the global scale of complex studies
- Understanding of regulatory obligations to manage compliance globally
- Simplified patient experience to drive quality data collection and enhance patient retention