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Mobile app and electronic clinical outcome assessment technology provide easy to use solutions for clinical trials
SAN DIEGO, June 16, 2014 /PRNewswire/ -- Bracket, a leading clinical trial specialty service provider, is demonstrating their most recent eClinical innovations this week at the 50th Annual Meeting of the Drug Industry Association. A mobile app, part of Bracket's Randomization and Trial Supply Management System (RTSM ) and Clinical Interactive Response Technologies (IRT) solutions, records subject visits and confirms medication dispensation, allowing site personnel to spend more time with patients and improving operational execution. The latest version of Bracket ePRO™ is also available for demonstration. Bracket ePRO ™ is an electronic clinical outcomes assessments (eCOA) solution used by patients, clinicians and other observers to record study data and answer questionnaires.
"We are pleased to announce the industry's first downloadable app with integrated barcode scanning capabilities to advance RTSM functionality. Our innovative technology-enabled solutions drive a paradigm shift in how investigators complete transactions at clinical sites and hospitals, providing them with more time to focus on their patients." said Jim Primerano, Senior Vice President and General Manager for the eClinical group at Bracket. "Having a mobile app directly connected to a Clinical IRT system for our clients' sites allows for better representation of their workflow. The inclusion of a built-in inventory scanning capability provides for point of dispensation verification checks to improve patient safety and dosing compliance, all while increasing accuracy of inventory management."
The Bracket RTSM app has bar code scanning capabilities, created with an eye toward the pending implementation of the Drug Supply Chain Security Act of 2013 which requires Data Matrix bar codes to be imprinted on all medication packaging. The system's dispensation tracking and mobile app bar code scanning can help prevent individuals from being dispensed the wrong medication, improve inventory recordkeeping and provide greater validity to study results in new drug application filings. The new app also enables site staff to sit with a patient and walk through the enrollment process. Bracket RTSM App is available for download in the App Store on iTunes for Apple iOS devices and in the Google Play Store for Android devices.
Bracket ePRO™ is a flexible platform for electronic clinical outcomes assessments (eCOA) that collects observations from patients (ePRO), clinicians (ClinROs) and other observers (ObsROs). The latest version of Bracket ePRO™ easily integrates with Bracket RTSM™ to reduce overall study enrollment time and management of ongoing data needs for trial sponsors, and it can be fully customized depending on the needs of any trial.
Bracket ePRO™ provides real-time synchronized data collection and results and is a cost effective alternative to paper surveys. As an integral research tool across a vast number of clinical trials, medication and disease management programs and comparative effectiveness studies, Bracket's ePRO platform has been used in over 70 countries and nearly 80 languages to optimize clinical research.
Bracket solutions serve clinical trial sponsors and their patients with patient-centric solutions using innovative software technologies that capture and report real-time experiences using smartphones, tablets, web and phone.
Bracket partners with sponsors and contract research organizations to achieve greater certainty and accurate outcomes in their clinical trials by providing a combination of scientific, technological and operational support, from Phase I to post approval. Bracket's eClinical services are technology-driven solutions, applicable across many therapeutic areas. Bracket RTSM™ technology is designed to support study design and operational effectiveness in clinical development. Bracket's Scientific Services target indications that are dependent on subjective endpoints (Clinical Outcome Assessments) to evaluate safety, efficacy and value, and include Endpoint Reliability, Trial Enhancement Services and Computerized Cognitive Testing.
Bracket is a member of the Electronic Patient-Reported Outcome (ePRO) Consortium, a program run by the Critical Path Institute (C-Path). The collaboration works to improve the quality of patient reported outcomes, a crucial element in the drug development process. Bracket leads the specialty services field in the U.S., U.K., Continental Europe and Japan. For more information, visit www.bracketglobal.com.
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