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Adherence specialists AARDEX Group and remote research platform experts in the Clinpal team at Cambridge Cognition have teamed up to provide next-level adherence monitoring during hybrid and decentralized clinical trials (DCTs). Integrating AARDEX Group’s MEMS® dosing capture and analytics system with Cambridge Cognition’s Clinpal DCT platform, including a video consultation, electronic Informed Consent and the research database provides sponsors and contract research organizations (CROs) with a seamless adherence management tool.
Dosing is captured digitally by MEMS®-connected medication adherence packaging and interrogated by the MEMS AS®, which can flag concerning medicine-taking behavior in real-time. The resulting data is synched directly to the Clinpal research database, which also collects data from participants, sites, and laboratories. The integration allows sites to access all study data, including adherence information, in one place. Clinpal manages the patient creation and linking, and participants can access adherence data through the Clinpal app. The result is an integrated, easy-to-use system that provides an optimal understanding of patient medicine-taking behaviors during the study while placing no additional burden on sites or participants.
The approach has been adopted by Trials@Home, a center of excellence for DCTs whose members include Sanofi, J&J, and Pfizer, and deployed in the project’s RADIAL study. The Phase IV clinical trial comprises around 600 people with Type 2 diabetes across 63 sites. Of these, 150 are site-based, 150 are hybrid, and up to 300 are participating fully remotely. Read the previous press release regarding the RADIAL study here.
Bernard Vrijens, CEO and Scientific Lead at AARDEX, said: “We are delighted to be progressing our strategic partnership with the Clinpal team at Cambridge Cognition. Poor adherence to the trial protocol can lead to safety concerns, underestimations of drug efficacy, and drain study power, even to the point of trial failure. Our digital medication adherence tool, MEMS AS®, offers a powerful suite of tools to measure and manage adherence to medication. This project is an opportunity to leverage our extensive practical experience in diabetes, including our recognized scientific leadership in medication adherence, to improve patient outcomes.”
Matthew Stork, CEO at Cambridge Cognition, said: “We are excited to partner with AARDEX Group delivering the best possible scientific data for clinical trials by monitoring and managing patient adherence. The integration with our Clinpal DCT platform provides a unified approach and easy-to-use solution for participants and sites and reduces the burden for sponsor in terms of integration and reconciliation efforts significantly.”
Both AARDEX Group and Cambridge Cognition will be present at the SCOPE Summit for Clinical Ops Executives in Orlando next week. Please visit booth 1025 to learn more.
