How Does Med-ic® Work?
The Med-ic® Electronic Compliance Monitor (ECM©) utilizes a CPU and attached printed sensor grid embedded in a medication blister package. The CPU records the time when a given tablet or capsule is expelled from its blister, and stores the data for later display and/or analysis. At the time of refilling the prescription or during a clinical trial follow-up visit, the patient's compliance data are downloaded to a PC via a CertiScan® RFID Reader, or downloaded using any NFC-enabled smart phone or tablet. CertiScan Software displays the information immediately on the PC using an intuitive graphic interface featuring point and click "drill down" capabilities ranging from daily to annual "at a glance" views. Using an NFC-enabled smart phone or tablet, compliance data can similarly be displayed directly on the device. Immediate display allows for on the spot targeted eduction to improve subsequent compliance. The data can also be exported to a variety of software solutions (eg: .pdf, .csv) for later use or analysis. CertiScan Software uses a secure proprietary trial data file (.tdf) to record, store, display and retrieve electronic records of compliance data. The software extends electronic record compliance with 21 CFR Part 11 back directly to the patient source. No patient information is stored on the CPU, ensuring confidentiality. CPU-resident data comprise simply a sequence of numbers representing time-events that can only be related to a patient when the study code is broken by the sponsor. Inputting compliance data collected by the traditional methods of patient reports, medication diaries and pill counts is costly. Med-ic eliminates the need for the double entry compliance data phase, dramatically reducing data entry costs while offering researchers the most reliable and valid records of patient adherence to the study regimen.