CertiScan® is IMC's proprietary solution to downloading compliance data from both Med-ic® and eCAP™. CertiScan and its associated Software use low-power RFID at 13.56 MHz to provide data security consistent with FDA 21 CFR Part 11. The data are stored on a PC where they can be displayed via an intuitive user interface incorporating point and click “drill down” views ranging from daily to annual records “at a glance”. This allows the clinical monitor to address any concerns about non-compliance immediately with the patient using targeted education, motivational counseling, or medication termination. The data can be exported in a number of formats to facilitate subsequent analysis and use (.pdf, .csv, etc).
CertiScan Software uses a secure, proprietary trial data file (.tdf) to record, store, display and retrieve compliance data. This software extends electronic record compliance with 21 CFR Part 11 right back to the source patient. By eliminating the double entry phase of compliance data input, CertiScan cuts data entry costs significantly while offering researchers the most reliable and valid record of patient compliance with a study regimen.
CertiScan compliance data can be displayed on screen or exported to other software applications
As the compliance data are stored in permanent memory on the CPU or in the trial data file (.tdf), they are available indefinitely for audit. To ensure confidentiality, no patient-linked data are stored on Med-ic or eCAP. Their data is simply a string of digits until the protocol code is broken by the sponsor.
Med-ic and eCAP compliance data can also be downloaded by Near Field Communication (NFC) and Bluetooth protocols including Bluetooth-LE. This flexibility allows data to be accessed in the field using any NFC- or Bluetooth-LE-enabled smart phone or tablet and displayed on the device. Data acquired in this way can also be sent by wireless (internet) or Global System for Mobile Communications (GSM - cell phone) to a central computer or cloud-based data repository for analysis and application.
Sophisticated electronics are contained inside every Med-ic ECM carded blister package and Log-ic tag