Schreiner MediPharm and AARDEX Group collaborated 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 the medication intake of trial participants, according to Schreiner MediPharm.
During clinical trials for new drugs, pharmaceutical companies must be able to depend on strict adherence to therapy regimens, Schreiner MediPharm noted.
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, the company said.
The therapy monitoring solution consists of smart medicine packaging linked to matching software.
Schreiner MediPharm said it 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, the company said.
This information is automatically stored and transmitted to a database via a smartphone app or reader, Schreiner MediPharm added.
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, Schreiner MediPharm said.
The data may be shared with defined stakeholders, the company added.
The comprehensive joint solution offered by Schreiner MediParm 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), according to the companies.
Also, they noted, 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.
“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," said 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," added Bernard Vrijens, Co-CEO & scientific lead of AARDEX Group. "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. 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."