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Digital therapy tools link drug packaging with matching software—with aim of enhancing participant monitoring
Schreiner MediPharm, a German specialty label developer, is collaborating with AARDEX Group, a digital solutions provider, to offer electronic options for medication adherence monitoring during clinical trials. The new offerings enable pharma companies to digitally monitor and manage medication intake of trial participants, while also enhancing compliance with the requirements and dosing regimens of clinical trial protocols proposed by FDA and the European Medicines Agency (EMA).
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, including 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.
As for the electronic therapy management, it is completed by AARDEX’s matching data platform, MEMS AS. This platform allows for the visualization and analysis of the data from the dosing history of the Smart Blister or Smart Kit Box.