Improved compliance monitoring for clinical trials

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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.

Smart Packaging Solutions Virtual Congress -19 March 2021

The Smart Packaging Solutions for India and South Asia Virtual Congress on 19 March focuses on food and pharma supply chains, brand security, and sustainability. Organized jointly by IPPStar and the AIPIA, the virtual congress’s topics include brand authentication, condition monitoring, and active and intelligent packaging that contributes to the safe delivery of authenticated products leading to safety, security, and customer engagement. Please look at the agenda of the conference here, and for registration, please click here. You can also email Ruchi at [email protected] or Umesh at subscri[email protected]. Call us in Noida at 120-4546988 or 4326053 – Umesh at Xtension 30; Ruchi at Xtension 33; Gaurav at Xtension 23; and Mohit at Xtension 25.

 

 

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