GOLDEN VALLEY, MN, USA, March 23, 2021 /EINPresswire.com/ — A New Paradigm for Capturing Real World Data in Clinical Research
Delve Health continues to expand its Clinical StudyPal platform with integrated wearables and sensor technologies to capture digital endpoints, including continuous vital signs, heart rate, motion, and behavioral monitoring. Delve Health’s Clinical Analytics Platform provides real-time insight into biometric data, sleep and activity levels. The platform uses various algorithms to capture adverse event (AE) indicators and provide real-time notification to investigators, sites and study teams remotely without adding patient burden or introducing compliance risk.
Digital endpoints captured automatically through the wearables include:
Biometrics: heart rate at rest, respiratory rate, skin and core body temperature
Behavioral monitoring: body position, activity level, sleep status
Symptomatic data: fall detection, chest tightness, cough and sneeze detection
Additionally, Clinical StudyPal collects task-based endpoints, such as blood pressure, blood oxygen levels, heart rate variability, 6 Minute Walk readings, and electrocardiogram results. Patients are responsible for wearing the device to capture these endpoints automatically and they are reminded with alerts to ensure data timeliness and improved compliance. Endpoints are provided in near-real-time through encrypted cellular data.
Using Delve Health’s Concierge Service coupled with Clinical StudyPal ensures that our team manages all aspects of digital sensors from the integration of the devices with the application and data platform to managing the logistics and operation of the wearables or devices globally.
“Ubiquitous Wearables, Mobile and Remote Sensors can be leveraged to provide information that can enable biopharma and medical device companies to access data in ways they never could before and thus change the way clinical research can be designed, ” says Wessam Sonbol (LinkedIn), co-founder and CEO of Delve Health. “99.9% of patient motions and activities occur outside of the doctor’s office. We want to capture patient activities and track any possible adverse reactions remotely while reducing patient’s burden. Our expanded offerings for FDA-approved wearable technology transforms study conduct by providing real-world evidence you can trust, while reducing, and in many cases eliminating, the need for site visits all while maintaining patient safety oversight.”
Through the Delve Health solutions, the company allows pharmaceutical and medical device sponsors, research sites, and clinical trial participants to perform and automate critical clinical trial operational tasks including clinical trial digital recruitment, study execution, compliance, and patient retention from any location worldwide. Delve Health’s modules span digital patient recruitment, remote consent (eConsent), patient-reported outcomes and surveys (ePRO), clinical outcomes assessment (eCOA), dosing management, remote vital sign management and sensor data collection. Clinical StudyPal seamlessly integrates all of this with home health and video visits to advance clinical research into the post-COVID-19 era.
“Our mission is to improve patient conduct in clinical trials, making it easier for them to be part of a clinical research study, while reducing their burden. Our technology can do so much more than digitizing the patient silos of the past. Collectively as an industry, it is our responsibility to enable new insights, new safety measures, and new levels of data analytics previously thought impossible without adding burden on patients, sites, or study teams. Wearable technology expands our offering of at-home digital endpoints to improve the accuracy and effectiveness of decentralized clinical trials,” says Sonbol.
To request a demo or start a conversation about how Delve Health can transform your next trial, visit www.delvehealth.com or contact [email protected]
About Delve Health
Delve Health has developed Clinical StudyPal as a platform to accelerate clinical trial enrollment and remote patient care, compliance, and retention. The company’s sole mission is to improve patient engagement in clinical trials, while enhancing collaboration between researchers, patients, and caregivers on-site and remotely. Clinical StudyPal is HIPAA, FDA CFR 21 Part 11, and GDPR compliant and validated, and is being used globally across different therapeutic areas. Learn more at www.delvehealth.com
