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Drug Discovery and Development

Pharmasol debuts new psiXchange capabilities to facilitate delivery of clinical trial safety documentation

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PharmasolPharmasol (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.

psiXchange 2.4

Filed Under: clinical trials, Drug Discovery
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About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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