Pharmasol (Kaiserslautern, Germany), a provider of pharmacovigilance software and services, has launched psiXchange version 2.4. The software automates the safety document distribution process within clinical trials.
The company created psiXchange software to manage documentation related to drug safety. The latest version of the software includes expanded site views, improved support of clinical operations and site-based teams. PsiXchange version 2.4 also supports the real-time dissemination of information to global stakeholders involved in drug safety management. Clinical research associates, for instance, using the software now have access to more robust status information. This feature supports compliance with the requirements of the FDA and European regulatory authorities.
The software can also immediately send safety documents such as suspected serious adverse reactions (SUSARs), line listings and development safety update reports to recipients such as ethics committee members, institutional review boards and clinical trial sites. The software automatically distributes such safety documents using embedded country rules and in recipients’ preferred language.
Previous versions of the software also had automated distribution for SUSARs, but version 2.4 offers more sophisticated support for this requirement. “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,” said Tim Billington, Pharmasol’s chief sales officer in a statement.
Version 2.4 automates “the entire drug safety document distribution process where documents are uploaded once and immediately made available to all appropriate recipients,” Billington said.
The software also offers comprehensive audit trails, monitoring and alerting capabilities.
