Your Trial is at Risk And
You Can’t Afford Non-Adherence!
The High Cost of Poor Adherence
You already know what happens when adherence fails.
Missed doses = compromised endpoints.
Protocol deviations = longer trials, higher costs.
FDA scrutiny = delays, lost funding, and frustrated
The question isn’t whether adherence tracking needs to improve.
The question is: Who will lead the shift toward validated adherence data?
The Industry is Moving— And
Trials MUST Adapt
The FDA is mandating real-world adherence tracking: Trials that rely on self-reporting are at risk of increased scrutiny, loss of funding, and approval delays.
Missed doses = corrupted data = trial failure: Deviations increase costs, cause delays, and put endpoints at risk.
Decentralized trials are becoming the norm: CROs need a passive, automated adherence solution to stay
The trials moving first will establish the industry standard. The ones that wait? They’ll get left behind.
RxKeeper® Pro:
The Only FDA-Registered, Battery-Operated
Cellular, Plug-and-Play Adherence Solution
FDA-Registered, Class I Medical Device
Fully compliant, patient-friendly, and currently deployed in the market.
Senior-Friendly: No Apps, No WiFi, No Smartphone Required
Patients don’t need to change their behavior. RxKeeper® Pro remembers so you don’t forget.
Cellular-Connected, Real-Time Adherence Tracking
The first battery-powered, always-on solution that ensures providers always know when medication is accessed.
Remote Therapeutic Monitoring (RTM) Billing Eligible
Generates revenue from Medicare with up to $136 per patient/month
in reimbursements.
AI Transforming Data Into Actionable Insights:
Supports clinicians with alerts, and outlier detection.
How RxKeeper® Pro Works:
Zero Friction, Maximum Adherence
AI Analytics for Predictive Personalized Care
AI Trend Analysis
Trend Analysis
Early Warnings
Clinical Decision Support
Automates decision-making
Detects patterns & outcomes
Alerts on clinical deviations
Assists physicians/nurses
Patients store their medication in RxKeeper® Pro.
RxKeeper® Pro reminds patients when to take medication.
It detects when medication is accessed.
Response‑to‑Therapy capture of Electronic Patient-
Reported Outcomes (ePRO)
Data is transmitted instantly via wifi or a secure cellular network.
Providers see real-time adherence reports.
Medicare is billed under RTM codes, and reimbursements are paid.
No behavior change. No patient training. Just compliance, data, and revenue.
RxKeeper® Pro: The First Passive Adherence
Solution Built for Clinical Trials
No Apps, No WiFi, No Behavior Change – Patients simply store their meds inside.
Battery-Operated, Cellular-Connected, Real-Time Adherence Tracking – Adherence data feeds directly into your RPM platform.
Seamless RPM Integration – No additional staff training is required.
Reduces Hospitalizations, Improves Outcomes – Providers retain patients, reduce costs, and improve quality scores.
In Stock & Ready to Deploy – No R&D, no delays—just revenue.
Benefits of ePRO and Medication Adherence in Clinical Trials
Benefits of Patient-Reported Outcomes (ePRO)
Better understanding of patient needs
Ensure better clinical outcomes
Real-time feedback rather than at scheduled site visits
Improves participant/protocol compliance
Significantly reduces data collection time
Higher quality data
Accelerates Clinical Trials while Improving Patient Compliance
Benefits of Medication Adherence
Increase efficacy
Helps identify compliance issues early on
Decrease the risk of complications
Decrease the risk of hospitalization
Nonadherence can increase variance, lower study power, and reduce the magnitude of treatment effects.
Increase low patient compliance with prescribed treatments, which is a common problem in clinical trials
How ePRO Works?
The Trials That Move First
Will Lead the Industry
Sponsors are demanding better adherence tracking.
FDA scrutiny is increasing—manual self-reporting won’t be enough.
CROs that deliver validated adherence data will win more sponsor contracts.
The shift is already happening.
Which CROs will own this space—and which will struggle to keep up?