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Transforming Clinical Trials with Decentralized Tele-Physical Exams
Gal3n enables efficient hybrid clinical trials and remote data capture. By deploying our platform (G-Carts onsite, G-Pods remotely), Principal Investigators (PIs) can perform complete physical exams including auscultation and specialty diagnostics using FDA-cleared peripherals. All data is captured securely and integrated into the eSource system for 21 CFR Part 11 compliance. This integration reduces visit delays, expands enrollment to rural patients, and positions your site as a preferred trial partner.
Background:
ClearView Research, a mid-size clinical site in North Carolina, was conducting a decentralized asthma trial but struggling to stay on schedule. The Principal Investigator (PI), Dr. Sarah Bennett, oversaw several studies at once and couldn’t always be onsite for physical exams. One participant, Laura Hernandez, a 58-year-old living 70 miles from the clinic, frequently missed visits due to transportation issues and fatigue from her condition. Each missed visit delayed data collection and risked sponsor dissatisfaction.
Challenge:
The site needed a way for Dr. Bennett to complete required physical exams remotely listening to lung sounds, reviewing vitals, and assessing patient symptoms without compromising data integrity or FDA compliance.
Solution:
ClearView adopted the Gal3n platform, installing a G-Cart in the main clinic and deploying a G-Pod to Laura’s local health center. During Laura’s next visit, a nurse assisted while Dr. Bennett joined through Gal3n’s secure telehealth interface. Using FDA-cleared devices including a digital stethoscope, otoscope, dermatoscope, and vitals monitor Dr. Bennett performed a full exam remotely, listened to Laura’s lungs in real time, and adjusted her treatment plan instantly. All data and recordings were automatically stored in the site’s eSource system, maintaining full 21 CFR Part 11 compliance.
Results:
Within three months, ClearView reduced visit delays by 60%, expanded enrollment to include more rural patients like Laura, and achieved higher sponsor satisfaction due to verifiable digital audit trails. Laura successfully completed her trial visits without missing a single appointment, reporting that she “finally felt cared for without having to travel hours for every checkup.”
Conclusion:
Gal3n transformed ClearView’s research operations by bringing hospital-grade oversight to decentralized settings. For patients like Laura, it meant accessible, real-time care. For Dr. Bennett and her team, it meant improved retention, faster data collection, and recognition as a trusted, tech-enabled site for modern hybrid clinical trials.
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