Development of Trumedicines Recognition Authentication Cloud Intelligence For Drug Product Surveillance (TRACI-4DPS) Software Solutions to Address FDA Post-Marketing Drug Surveillance Challenges

TruMedicines Fast Track SBIR ApplicationProject Summary TruMedicines is a Seattle based software technology company that provides the Trumedicines Recognition Authentication Cloud IntelligenceTRACImobile software solutions to address requirements of theDrug Security Act to tracktraceand authenticate of drug packagesOur functional practice areas include mobile app developmentimage recognitionsecure data storageimage retrieval and text to speech messagingTRACI uses our patented pattern recognition algorithms to authenticate individual addressable drug unitsADUsThis allows ADU trackingtracingand authenticationwhich has never been possible beforeThe software identifies ADUsallows users toscan a pill to log into the systemand provides an interactive device to communicate in real time directly to study administratorsThrough this Phase I SBIR applicationTruMedicines will develop a new productTRACIDPSTRACI for Drug Product Surveillanceto address the FDA CDER s interest in collecting usable data on post marketing drug product use and communicationsTo complete development and testing of our productTruMedicines has partnered with investigators from the University of Washington Deptof Psychiatry andampBehavioral Sciences and the Global Medicine Centerto focus onSpecific AimsAimDevelop targeted software to create easy to use tools for communication between patientsphysicians and health care providers that willatrack physician prescribing behaviorbcommunicate newly identified risks to patientsand ccollect data on drug associated events to include in real time expectedunexpected and adverse eventsAimDevelop software to provide advanced statistical analyses and display graphical charts of data resulting from Aimthat can be shared with healthcare providersregulators and researchersThe statistical analyses and graphs will be accessible forpersonal use by the patient and healthcare provider sandanonymous HIPPA compliant for regulatory oversight and research studiesand AimCreate a panel of patientsproviderspharmacists and regulators to testevaluateand provide feedback on TRACIDPS that will be used to refine our product in the Phase II applicationResults of the enhanced software development and testing will be used to develop our Phase II SBIR applicationwhich includes testing for feasibility in a small clinical trial that will partner patients with their healthcare provider sand physiciansAdditionallywe will use the results of our Phase I project to develop our Plan for Commercialization as we believe that our unique product fills a gap in mobile technology for healthcare as apersonal healthcare assistantand is particularly suited to the FDA s challenges in gathering data on drug use surveillance TruMedicines FDA Phase I SBIR ApplicationProjective Narrative TruMedicines is a Seattle based software technology company that provides the Trumedicines Recognition Authentication Cloud IntelligenceTRACImobile software solutions that are focused on authentication of individual addressable drug unitsADUsThis allows ADU trackingtracingand authenticationwhich has never been possible beforeThe software identifies ADUsallows users toscan a pill to log into the systemand provides an interactive device to communicate in real time directly to healthcare providersdrug study administratorsor pharmaceutical organizationsThrough this Phase I SBIR applicationTruMedicines will develop and test their new productTRACIDPSTRACI for Drug Product Surveillanceto address the FDACDER s interest in collecting usable data on post marketing drug product use and communications