Clinical trials rely on accurate data. But what if one of the most important variables whether a patient actually takes the medication is based on guesswork? Traditional methods like pill counts, diaries, or verbal confirmation have long been the standard, but they fall short. Enter electronic monitoring: a smarter, more reliable way to capture adherence in real time. In this article, we’ll explore what electronic monitoring is, how it works, and how sponsors and CROs can use it to run cleaner, faster, and more successful trials.
What is electronic monitoring?
Electronic monitoring refers to the use of smart tools like electronic pill bottles or packaging, that record exactly when a patient accesses their medication. These tools don’t track ingestion directly, but they provide a reliable proxy by logging every time a medication container is opened. The data is time-stamped, stored securely, and often transmitted in real time to researchers.
The most widely used tool is the Medication Event Monitoring System (MEMS®), developed and validated over several decades by AARDEX group. MEMS cap is a cap that fits on standard medication bottles and automatically records each opening as a presumed dosing event. This simple action creates a digital sign of adherence that is more accurate than pill counts or self-reports.
Why traditional methods fail
Despite being widely used, traditional adherence monitoring methods are prone to error:
Pill counts can be manipulated or inaccurate.
Patient diaries are subject to forgetfulness or falsification.
Self-reports suffer from recall bias and social desirability bias.
These approaches lack granularity. They don’t tell you when a dose was missed, if doses were bunched together, or if treatment was paused altogether.
Electronic monitoring offers a higher-resolution view of patient behavior. For sponsors and CROs, this means:
- Data you can trust. Objective, time-stamped records reduce ambiguity.
- Early warning signals. Patterns of poor adherence can be spotted before they affect trial outcomes.
- Stronger trial integrity. Real-time data supports regulatory expectations and robust risk-based monitoring.
- Better patient engagement. Adherence dashboards and automated reminders support patient empowerment and accountability.
Use cases in different trial phases
In Phase II, adherence data helps determine dose-response relationships. If adherence is poor, even effective treatments can appear ineffective.
In Phase III, poor adherence can increase variability, requiring larger sample sizes and increasing trial costs. Real-time monitoring allows interventions that keep patients on track.
In post-marketing studies, adherence data helps identify real-world behavior and informs risk management strategies. It can also feed into health economic models, influencing payer decisions.
One of the biggest misconceptions is that electronic monitoring is difficult to implement. In reality, systems like MEMS integrate smoothly into existing workflows:
- Training is minimal as patients use a familiar container.
- Data is secure and GCP-compliant, meeting global regulatory standards.
- Dashboards offer real-time visibility for sponsors, sites, and monitors.
- Alerts and notifications always support proactive interventions.
AARDEX group’s role
At AARDEX Group, we offer more than just hardware. Our complete adherence management platform includes electronic monitoring devices, cloud-based data dashboards, analytics tools, and expert support. We help sponsors not only collect high-quality adherence data but also interpret and act on it to improve outcomes.
Our solutions are built to align with ICH E6(R3) and ICH E9(R1) guidance, supporting ESTIMAND-based thinking and risk-based quality management (RBQM). Whether you’re designing an early-stage study or managing a complex global trial, we help bring clarity to medication exposure.
Adherence data is no longer a nice-to-have, it’s essential. Electronic monitoring brings reliability, precision, and real-time visibility to one of the most important variables in clinical trials. For sponsors and CROs aiming to improve data quality, reduce trial risk, and meet regulatory expectations, adopting these tools isn’t just smart, it’s necessary decision.
Contact us to learn more.
