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Tools for Clinical Trials Professionals
Software digitizes the entire clinical trial source and lifecycle management process
Precerche Life Sciences, LP (Austin, TX) is offering a twist to traditional clinical data management software packages. Its InterRx platform integrates all source data, along with data capture and trial operational metrics, into the digital trial management solution. This saves users the time and trouble of keeping secondary systems to monitor the trial's operational and clinical effectiveness, says the manufacturer.
InterRx is a versatile tool with diverse utilization opportunities. It can serve as a hosted digital trial research or management solution for decentralized sites, or as part of a rapid deployment CRO solution. The platform enables rapid protocol implementation, trial and data management, patient safety, team communications, real-time trending analytics site efficiency, enrollments, and FDA submission preparation.
Its manufacturer says InterRx reduces study start times 60%–70% on average. The suite of InterRx packages includes InterRx Data Manager, InterRx LifeCycle, and InterRx CRO.
Precerche Life Sciences, LP, (512) 233-0197, www.precerche.com
Server-connected dispensing bottle puts a new spin on automated patient compliance
Clinical Technology Advisors (Acton, MA) has a fail-safe patient compliance technology that relies on an everyday tool: cell phones. The SIMpill Medical Compliance System consists of a pill bottle that is connected to a module with cell phone components. When a patient opens the cap on the pill bottle, an SMS message is sent via a wireless network to a secure central server that documents the event. If the server does not detect a cap removal by a certain time, it sends a message to a designated caregiver's cell phone. If this does not prompt the patient to remove the bottle cap, a follow-up message is sent 15 minutes later.
SIMpill Medical Compliance System
The dispenser's manufacturer, UK-based SIMpill (Pty.) Ltd, says GSM networks reduce reliance on physical networks, making the device more widely usable in developing communities. Trial monitors can verify compliance in real time via the Web-based interface feature. Data on compliance levels measured by the device are stored for future analysis.
Clinical Technology Advisors, (978) 263-9596, www.clintechadvisors.com
Latest release promises to further expand open source software's interoperability prowess
Akaza Research (Cambridge, MA) is adding new interoperability features to its OpenClinica open source, Web-based software platform, designed to enable sponsors and investigators manage clinical research data in multisite studies. Highlights of the suite's new capabilities include enhanced EDC and data management, new tools for study coordinators and monitors to conduct source data reviews, and data output in SAS and CDISC XML format.
Also notable is OpenClinica's improved data persistence layer, which enables compatibility with the NIH caBIG project, facilitating research in the cancer arena. This version, which is undergoing beta testing, will also feature compatibility between electronic data collection instrument and CRF metadata models. This feature will support a platform-independent CRF definition through HL7v3-compliant XML-based messaging.
Akaza Research, (617) 621-8585, www.akazaresearch.com