Schreiner MediPharm, a Germany-based global provider of functional label solutions for the healthcare industry, has collaborated with AARDEX Group, provider of 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, which 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 is designed to enhance compliance with the requirements and dosing regimens of the Clinical Trial Protocols proposed by the 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.
All of Schreiner MediPharm’s smart package solutions are now compatible with the AARDEX MEMS adherence software systems. AARDEX is seeking to open its platform to a variety of smart pharma packaging and smart devices to cover all route of drug administration.