pharmasol, a leading global provider of software and services for pharmacovigilance activities today announces the availability of psiXchange version 2.4, which automates the safety document distribution process within clinical trials.
psiXchange, the dynamic safety data communication hub for drug safety document management, is an automated system that establishes relationships between data from multiple sources. The new enhancements within this release include expanded site views, enabling better support of clinical operations and site-based teams, and it provides enhanced information in real-time to a variety of global recipients involved in the drug safety management chain. For example, more powerful status information is now directly available to Clinical Research Associates (CRAs) whose responsibilities include accurate record keeping at clinical trial sites, critical for compliance and necessary for the reporting process for approvals by the Food and Drug Administration (FDA) and European regulatory agencies.
Safety documents like suspected unexpected serious adverse reactions (SUSARs), line listings and development safety update reports (DSURs) can be immediately sent to all recipients including sites, ECs (ethics committees), IRBs (institutional review boards) and others through Safety Central (the smart portal that is part of psiXchange), reducing the number of outgoing messages, leading to greater transparency, time-savings and reduced costs. These safety documents are automatically distributed using the embedded country rules and recipients’ language preferences.
“psiXchange was specifically created for SUSAR distribution and designed to meet this exact business requirement,” said Tim Billington, pharmasol’s Chief Sales Officer. “This new version of psiXchange builds on its existing automated distribution process, which eliminates the need for expensive set-up costs for each new study by reducing or eliminating manual efforts. The hub effortlessly integrates with existing systems, safeguarding investigators, study teams and compliance personnel from potential implementation headaches. In essence, pharmasol has completely automated the entire drug safety document distribution process where documents are uploaded once and immediately made available to all appropriate recipients.”
With its innovative approach, psiXchange includes comprehensive audit trails, combined with monitoring and alert mechanisms to enable full compliance in highly regulated industries. By building on existing safety delivery methods, psiXchange can be seamlessly implemented without the need for recipient training. The system has achieved high levels of user acceptance and automated compliance, thus saving resources. Customers have reported an 80% reduction in costs, 90% reduction in resource requirements and are experiencing compliance rates above 97%.
About pharmasol and psiXchange
Founded in 2001, pharmasol is a provider of innovative drug safety software and services for Clinical Research Organizations (CROs), pharmaceutical and medical device companies worldwide. Focused on pharmacovigilance IT and business process support, this seasoned team of industry experts facilitates improvement across the entire PV function. With our in-depth global experience in deploying, maintaining and supporting global pharmacovigilance (PV) databases, pharmasol helps organizations from small start-up CROs to global industry players. For further information about pharmasol, please visit: www.pharmasol.de
For clinical trial management when organizing and distributing training and safety documentation, psiXchange is the only out-of-the-box software available that was specifically created to handle SUSAR distribution, but that can also be tailored to provide custom features that are accessible directly via Safety Central (the psiXchange smart portal). By automating the entire business process, pharmasol delivers improved compliance, greater oversight and significant cost savings. Global offices for pharmasol are located in Germany, the UK and the U.S. For further information about psiXchange, please visit: www.psiXchange.com.