Schreiner MediPharm, a Germany-based global provider of specialty pharmaceutical labeling solutions for over 65 years, working in conjunction with the Dutch technology company ECCT (Experts in Communications & Connectivity Technology), has developed a smart blister pack for a global pharmaceutical corporation to enhance medication adherence by clinical trial participants. The introduction of this innovative electronic tool for managing and tracking processes during clinical trials marks a milestone for this global group of companies.

While clinical trials require high accuracy, reliable workflow, efficiency, speed and flexibility, the conventional, non-automated processes are frequently error-prone. Medication adherence by participating patients is critical for the successful outcome of clinical trials, but often difficult to track. Usually, about 20 percent of patients do not adhere to medication therapy, forcing trial organizers to compensate for the resulting accuracy deficit by increasing patient populations up to 60 percent.

To improve medication adherence, Schreiner MediPharm joined forces with ECCT and the pharmaceutical corporation involved to develop a smart packaging solution for patient compliance monitoring. The solution works as follows: When a patient pushes a tablet from the blister pack, data is generated in real time. This data may include medication type, extraction time and specific cavity, and is automatically stored in the smart packaging and transmitted to a database via smartphone app or reader.

This digital therapy monitoring allows physicians, for example, to verify that patients have taken their medicine at the right time. Additionally, the technology makes interactive communication between physicians and patients possible. For instance, physicians can send compliance reminders or dose adjustments to patients.

The smart packaging solution includes printed electronics without impacting the packaging design, and a smart database platform enables diverse data transfers and analyses. Schreiner MediPharm supplied the required expertise in innovative printing technology, and ECCT provided the package’s smart sensors.

The benefits of utilizing this innovative digital patient compliance monitoring tool include:

• Increased efficiency of the clinical trial process as a result of reduced manual documentation and monitoring
• Enhanced data quality and reduced delinquency rate due to non-compliance
• Greater flexibility in adjusting complex therapies and trial workflows
• Shortening of trial periods and accelerated approval process for new medicines