Improved compliance monitoring for clinical trials

During clinical trials of new drugs pharmaceutical companies must be able to depend on strict adherence to therapy regimens. But up to 50% of patients involved in trials do not adhere to the prescribed dosage regimen, resulting in distorted outcomes and delayed time to market. So Schreiner MediPharm and AARDEX Group have developed an electronic solution for medication adherence monitoring to digitally monitor and manage medication intake of trial participants.

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

Data are 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, an expert in digital medication adherence solutions. Its MEMS AS®, enables the visualization and analysis of the data from the dosing history and can be shared with defined stakeholders. 

This solution 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 behaviour.

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“Our partnership with AARDEX combines unique smart packaging technology, which can be scaled up via roll-to-roll processes into large commercial volumes, with the necessary intelligence from AARDEX,” says Stefan Wiedemann, senior director strategic marketing and business development at Schreiner MediPharm.

“These smart package solutions are now compatible with the AARDEX MEMS® adherence software. 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. Our strategy is to open the platform to a variety of smart pharmaceutical packages and smart devices,“ said Bernard Vrijens, co-CEO &scientific lead of AARDEX Group.

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