Real Time Data for Clinical Trials
Dose Recognition Program is a new app for mobile phones intended for clinical trials. The primary function of DR is to measure patient compliance. This critical data is securely recorded & sent to a dedicated server. All transactions are real time, wireless & include the date, time & sequence of the patient medication regime. The core invention of DR is patent applied technology. DR is designed as a communication tool with existing packaging formats or blister packs.
Benefits of Dose Recognition:
- Reminder System
- Better Adherence
- Miss-Dosage Prevention
- Improved Data Accuracy
- Cost Reduction
Mobile Application – Dose Recognition Technology
|1. Launch DR App||2. Take Picture of Blister Pack||3. Upload Data||4. Manage data|
DR App is available for iPhone®, iPod® touch, iPad®, and Android devices
DR App Collects Compliance Data
|a) Using a mobile communication´s camera to record the individual pill opening of a blister package.b) Using the Dose Recognition system to analyze this image file. To gather information on the user’s compliance with their pharmaceutical program.
c) The Dose Recognition system will detect whether a particular individual pill seal within the blister package has been broken using image recognition software.
d) The automated system collates the data issued by individual mobile communication devices by updating a database and queries it against pre-set parameters set by an individual patient’s relevant health care professional.
|e) The automated system issues reminders, delivers visual instructions and information to patients through the application on the mobile communication device. This is triggered by the data uploaded from the mobile communication device.f) The Dose Recognition system issues reminders and information to the healthcare professionals through the web based platform provided by the service. This is triggered by the data upload from the mobile communication device.
g) The database of patients held on the server can be downloaded by relevant and authorized health care practitioners using a web based platform by the service.
Regulatory Concerns: It is essential that new technologies conform to regulations and guidelines in the highly regulated pharmaceutical industry. The Dose Recognition Mobile Phone Technology, complies with both the US Health Insurance Portability and Accountability Act of 1996 (HIPPA) and the UE Directive 2002?58/EC (Directive on privacy and electronic communication). This ensures that all data are encrypted to 256 bits, patients consent is obtained before communication begins, and that there is a simple opt-out service for patients or sites. Additionally, the SMS technology has full message tracking capabilities and generates delivery reports to ensure patients have received the messages. The technology provides a full audit trail in line with these regulations. Our partners computer systems are validated to comply with FDA 21 CFR part 11 guidelines..