Ready to transform your healthcare monitoring? Let's talk.
Remote Research. Audit-Ready. Accelerated Trials.
Gal3n is the only diagnostic telemedicine platform built for modern clinical research. We enable decentralized trial models by combining FDA-cleared diagnostic devices with remote PI oversight, ensuring high-quality, audit-ready data without adding site infrastructure or participant burden.
Gal3n is designed to turn your operational limits into strategic advantages, allowing you to maximize enrollment and oversight while strengthening compliance. By reducing participant burden and eliminating unnecessary travel for key personnel, our platform unlocks new capacity to run more studies simultaneously with superior data quality.
Who we serve
CROs
Research Sites
Transform Trial Operations, Participant to PI
Gal3n is the strategic solution that fundamentally improves trial success across every stakeholder. By providing the tools to expand your participant reach and streamline your PI's time, our platform delivers an efficient, compliant, and patient-centered research experience.
Recruitment & Reach
Instantly expand your recruitment pool beyond local zip codes to include diverse, rural, and mobility-limited participants, meeting critical FDA inclusion mandates.
Compliance & Quality
FDA-cleared Digital Health Technologies (DHTs) with automatic metadata logging, guaranteeing all remote data aligns with 21 CFR Part 11 and GCP standards.
Optimized Schedules
PIs structure their day more efficiently, balancing oversight across multiple trials without travel interruptions.
Reduce Participant Burden
Minimizing travel time and costs results in higher enrollment rates, better adherence, and stronger retention.
Experience the Future of Accelerated Clinical Trials
Get Started with Gal3n
Grow trial capacity while keeping site overhead costs flat. A complimentary, no-obligation demo is your opportunity to see our FDA-cleared diagnostic platform and remote PI oversight features in action. You will learn exactly how Gal3n enables a compliant, scalable decentralized trial model to drive more revenue and ensure superior study outcomes.
Gal3n fundamentally changes the economics of running a clinical trial. Our platform reduces the cost per participant while creating new capacity, allowing your research site to accelerate study timelines, and maximize sponsor funding.
Verified and Validated DHTs
Gal3n’s peripherals — including digital stethoscopes, otoscopes, dermatoscopes, HD cameras, and vitals monitors — are FDA-cleared, ensuring that measurements are accurate, precise, and clinically appropriate for use in trials.
Audit-Ready Documentation
All video, images, and diagnostic data captured through Gal3n are automatically logged with metadata, creating transparent audit trails that meet FDA, GCP, ICH, and IRB standards.
Secure Data Integrity
Gal3n provides secure transmission and storage of participant data in compliance with HIPAA and 21 CFR Part 11, protecting privacy while ensuring records are durable, traceable, and regulator-ready.
Remote PI Oversight Within FDA Standards
By enabling PIs to supervise and document exams remotely, Gal3n supports FDA’s goal of making DHTs a reliable pathway for decentralized clinical trials (DCTs), while preserving the quality and integrity of investigator oversight.
Industries
Our innovative solutions serve a wide range of healthcare facilities, ensuring quality care and monitoring across different environments.
Hospitals
Comprehensive monitoring solutions for acute care environments and critical patient management.
Nursing Homes
Specialized care monitoring for elderly residents requiring continuous health supervision.
Long-term Care
Extended monitoring solutions for patients requiring ongoing medical attention and care.
Diagnostic Centers
Advanced diagnostic monitoring for treatment facilities and specialized medical centers.
Success by the Numbers
Real results from healthcare providers using Gal3n
500+
Healthcare Providers
2M+
Patients Served
85%
Efficiency Improvement
4.9
Customer Rating
Frequently Asked Questions
How does Gal3n enable at-home remote study visits for participants?
Gal3n redefines trials by enabling at-home remote study visits using FDA-cleared diagnostic devices and real-time telehealth. This approach reduces participant burden (eliminating travel and cost), improves adherence and retention, and allows sites to recruit from anywhere, including rural, underserved, and mobility-limited populations.
What is Gal3n's role in ensuring regulatory compliance and data quality?
Gal3n ensures strict compliance by using FDA-cleared Digital Health Technologies (DHTs) for accurate data collection. The platform is HIPAA-compliant and 21 CFR Part 11-ready, automatically logging all video, images, and diagnostic data with metadata to create audit-ready, transparent trails that meet FDA, GCP, and ICH standards.
Can research sites expand capacity without costly infrastructure changes?
Yes. Gal3n helps sites grow trial capacity while keeping site overhead costs flat. By shifting routine follow-up visits into the home setting, sites can manage more participants simultaneously without needing larger facilities or additional exam rooms. This makes the site more competitive in winning new studies.
How does Gal3n benefit Contract Research Organizations (CROs)?
For CROs, Gal3n enables standardized remote monitoring and oversight across their network. This leads to a reduction in protocol deviations, faster query resolution during audits, improved patient retention, and higher sponsor satisfaction. Ultimately, it positions the CRO as a leader in efficient, compliant decentralized trial execution.
What specific diagnostic devices can be used by the PI remotely?
Gal3n integrates FDA-cleared diagnostic peripherals to ensure clinical-grade data. These devices include digital stethoscopes (for heart/lung auscultation), otoscopes, dermatoscopes, HD cameras, and vitals monitors, allowing the PI to perform a complete physical exam remotely with the necessary diagnostic precision.
How does Gal3n transform the Principal Investigator (PI) oversight model?
Gal3n eliminates the need for PIs to travel between sites, offering PI Flexibility. Investigators can connect from anywhere to oversee full physical exams, interact with participants, and guide staff in real-time. This optimizes PI schedules, allowing them to supervise more participants and sites, ultimately accelerating trial progress and expanding research capacity.
Get In Touch
Ready to transform your healthcare monitoring? Let's talk.
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