Schreiner MediPharm, a Germany-based global provider of innovative functional label solutions for the healthcare industry, has collaborated with AARDEX Group, an expert in digital medication adherence, to offer electronic solutions for medication adherence monitoring during clinical trials. The new offerings enhance therapy adherence in clinical trials, enabling pharmaceutical companies to digitally monitor and manage medication intake of trial participants.

During clinical trials for new drugs, pharmaceutical companies must be able to depend on strict adherence to therapy regimens. However, up to 50% of patients involved in clinical trials do not adhere to the prescribed dosage regimen, resulting in distorted outcomes such as insufficient drug efficacy or underestimated frequency of side effects. Ultimately, these adverse events can delay time to market.

The therapy monitoring solution consists of smart medicine packaging linked to matching software. Schreiner MediPharm has developed Smart Blister Packs for tablets and capsules and Smart Kit Boxes for vials and syringes with sensor technology for this solution: When a patient extracts a tablet from a cavity or removes a vial from a compartment, real-time data are generated such as time of removal, compartment from which the product is extracted, and dose. This information is automatically stored and transmitted to a database via a smartphone app or reader.

The electronic therapy management is completed by the matching data platform from AARDEX. The leading expert in digital medication adherence solutions provides MEMS AS®, a special platform enabling the visualization and analysis of the data from the dosing history of the Smart Blister or Smart Kit Box. The data may be shared with defined stakeholders.

The comprehensive joint solution offered by Schreiner MediParm and AARDEX Group enhances compliance with the requirements and dosing regimens of the Clinical Trial Protocols proposed by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In addition, it enables the detection of structural deficiencies and collection of important data about patient behavior that can be used for marketing strategies and other purposes.

“Our partnership with AARDEX combines Schreiner MediPharm's unique smart packaging technology, which can be scaled up via roll-to-roll processes into large commercial volumes, with the necessary intelligence from AARDEX. This cooperation will enable us to leverage the full potential of medication adherence in clinical trials and commercial environments. We look forward to supporting our customers with a complete solution and joint consultancy expertise,” says Stefan Wiedemann, Senior Director Strategic Marketing and Business Development at Schreiner MediPharm.

“All of Schreiner MediPharm’s smart package solutions are now compatible with the AARDEX MEMS adherence software solutions to manage patient adherence in clinical trials. This partnership reinforces the position of the AARDEX digital interface and back-end platform as a unique solution to collect, analyze, and manage medication adherence data in clinical trials. It is aligned with our strategy to open the AARDEX digital platform to a variety of smart pharmaceutical packages and smart devices to cover all routes of drug administration,“ said Bernard Vrijens, Co-CEO & Scientific Lead of AARDEX Group.