Schreiner MediPharm and AARDEX offer smart digital therapy management solution for clinical trials
During clinical trials of new drugs pharmaceutical companies must be able to depend on strict adherence to therapy regimens. However, up to 50 percent 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 and delayed time to market. To enhance therapy adherence in clinical trials, Schreiner MediPharm (Oberschleißheim, Germany) and AARDEX Group (Seraing, Belgium) offer an electronic solution for medication adherence monitoring enabling pharmaceutical companies to digitally monitor and manage medication intake of their trial participants.
The therapy monitoring solution consists of smart medicine packaging linked to matching software. Schreiner MediPharm 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. These 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. The leading expert in digital medication adherence solutions provides MEMS AS, a special platform enabling the visualisation 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 complete solution jointly offered by Schreiner MediPharm and AARDEX Group enhances compliance with the requirements and dosing regimens of the Clinical Trial Protocols proposed by the U.S. 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 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, analyse, 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.
Caption: With the MEMS AS Platform from AARDEX, the data from the dosing history of the smart packaging from Schreiner MediPharm are visualised and analysed (photo: Schreiner Group)