AARDEX Group

Adherence Packaging -- !>

CleverCap Lite Pill Dispenser

CMT's digital pill dispenser, CleverCap Lite is a powerful tool designed to help individuals with chronic conditions manage their medication regimen and improve adherence while participating in clinical trials. With a user-friendly design, CleverCap Lite has proven to help people improve their medication adherence and achieve better health outcomes. Additionally, CleverCap Lite is integrated with AARDEX Group's adherence software, which provides researchers with real-time medication adherence statistics, allowing for more accurate and reliable clinical trial results.

How Does the Pill Dispenser Work?

Managing chronic conditions and maintaining good health often requires participants to follow strict med adherence instructions. Still, this can be overwhelming for patients participating in clinical trials with complex medication schedules. CMT's digital pill dispenser, CleverCap, offers a solution to simplify the medication-taking process and ensures clinical trial participants stay on track with their regimens. CleverCap automatically timestamps when medication is dispensed, and this dosing data is transmitted to AARDEX Group's MEMS AS® medication adherence software.

MEMS AS analyzes the dosing data to identify erratic dosing patterns, overdoses, and other behaviors that require attention. Investigators can quickly identify participants who need additional coaching and support using the dashboards provided. This proactive approach to medication adherence monitoring allows investigators to optimize adherence, enhance patient outcomes, and ensure the accuracy and reliability of clinical trial data.

FEATURES

Adherence Insights in
Real-Time.

With CleverCap's user-friendly design and MEMS AS's advanced software features, clinical trial investigators can access real-time insights on med adherence. This proactive approach to monitoring medication adherence enables researchers to identify adherence issues and take appropriate measures to ensure participants stay on track with their medication regimens. This comprehensive solution enhances patient outcomes, guarantees the accuracy and reliability of clinical trial data, and improves the overall success of clinical trials.

FEATURES

Measure Med Adherence Precisely.

Compared to traditional medication adherence monitoring methods like pill count, self-report, and PK sampling, our approach offers unparalleled accuracy and a variety of additional features. Studies have demonstrated that dispensers, such as CleverCap, have an impressive 97% accuracy rate in tracking and collecting participant medication events, surpassing PK sampling at 70%, pill count at 60%, and self-report at just 27%. By utilizing our advanced med adherence solutions, clinical researchers gain access to highly precise data that inform safety and efficacy calculations, enabling them to make informed decisions.

FEATURES

Adherence-Enhancing Features.

CleverCap provides a solution to simplify the medication-taking process and ensure that participants stay on track with their medication regimen. CelverCap's combination of light and sound alerts participants when it's time for their next dose, providing gentle reminders that are easy to customize and use. The lights on the cap flash and a gentle chime sounds when it's time for a dose. These gentle reminders are designed to be unobtrusive and won't disrupt daily routines or draw unwanted attention. Additionally, CleverCap offers personalized reminders and feedback messages delivered via phone or text, depending on the participant's preference. These messages can alert participants if they are late taking a dose and provide a customized approach to medication management.

FEATURES

Companion App for Participants.

Our patient-centric approach to medication adherence in clinical trials is rooted in the belief that eliminating barriers to adherence is critical for optimizing participant outcomes and maintaining research integrity. Our user-friendly solutions require no additional burden on participants, simply asking them to take their medication as prescribed. Furthermore, our innovative solutions include MEMS® Mobile, a convenient app that enables participants to schedule medication reminders and keep track of their dosing regimen. By empowering participants to take control of their medication management, we strive to help them achieve the best possible outcomes.

FEATURES

FDA Guidance Compliant.

The FDA’s guidance, “Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products,” is a clear call to action for the research industry to prioritize medication adherence. As part of this effort, the FDA is advocating for the use of smart pill bottles to encourage patients to take their medications as prescribed. By leveraging technology in this way, researchers can take a proactive approach to medication management, delivering more personalized and effective care.

OUR CLIENTS

The Go-To Solution for Pharma Companies

Some of the world's leading pharmaceutical companies have embraced our medication adherence solutions. From global giants to niche players, these organizations have recognized the value of our innovative solutions for enhancing medication adherence, reducing costs, and improving patient outcomes. It's an honor to partner with these remarkable brands, and we're proud to contribute to their efforts in advancing healthcare.

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Frequently Asked Questions

Med adherence is a vital yet often overlooked aspect of successful research. That's why we've gone the extra mile to gather and organize the most frequently asked questions about this critical topic. Our goal is to empower researchers and patients alike with the knowledge they need to ensure medication adherence is never a hurdle to progress. So, without further ado, here are the answers you've been looking for!

Med adherence, or medical adherence, refers to the degree to which a participant follows the prescribed medication regimen. It includes taking medication at the right time, in the right dosage, and in the right way, as outlined in the protocol. Adherence is crucial for the effectiveness of treatment and can be critical in managing chronic conditions or diseases. Non-adherence to medication can lead to worsening health outcomes, increased healthcare costs, and even death.

 

There are several methods including:

  1. Self-Report: Patients may be asked to report how well they have been following their medication regimen. This can be done through questionnaires or interviews.

  2. Pill Count: This involves counting the number of pills or doses of medication a patient has taken over a specified period. This method is simple and cost-effective but relies on the patient’s honesty and accuracy in reporting.

  3. Medication Event Monitoring System (MEMS): MEMS devices are pill bottle caps or blister packs with electronic monitors that record each time the container is opened. This method provides an accurate record of when medications are taken.

  4. Biomarkers: Some medications can be detected in blood, urine, or saliva, providing objective evidence of medication ingestion. 

In clinical trials, several methods may be used to assess medication adherence, including those mentioned above, as well as medication diaries or electronic monitoring systems. The choice of method will depend on the specific needs of the trial and the medication being studied.

 

It is important in clinical trials for several reasons:

  1. Accurate Data: The effectiveness of a medication can only be accurately evaluated if the patient takes the medication as prescribed. Poor adherence can lead to inaccurate data and may affect the ability to draw meaningful conclusions from the trial.

  2. Safety: Non-adherence to medication can result in adverse events or unexpected safety issues, which can compromise the safety of trial participants. It is crucial to ensure that patients take the medication as prescribed to minimize the risk of adverse events.

  3. Regulatory Compliance: Regulatory authorities require that clinical trials adhere to strict protocols and guidelines. Ensuring medication adherence is a critical aspect of protocol compliance, and failure to do so can result in regulatory non-compliance.

  4. Cost-Effectiveness: Poor adherence can result in extended trial timelines, increased costs, and reduced return on investment. Ensuring medication adherence is an important aspect of optimizing trial efficiency and cost-effectiveness.

Overall, medication adherence is a critical component of clinical trial success, as it ensures accurate data, patient safety, regulatory compliance, and cost-effectiveness. It is important to implement strategies to monitor and improve adherence in clinical trials to ensure the validity of trial results and the safety of trial participants.

WEBINAR WITH MERCK & BIOGEN

Mitigating the Risk of Poor Adherence in Trials

Watch this live recording with adherence experts from Merck & Biogen to learn about their approach to mitigating the risk of poor adherence in trials.

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Collaborating for Safer, More Efficient Trials.

By combining technology and partnerships, we are revolutionizing how medication adherence is monitored in clinical trials. Our unique adherence ecosystem brings together leading medication adherence packaging and devices and DCT, IRT, and EDC vendors, CROs, and CMOs to drive innovation.