California, US-based Veeva Systems, created Vault Safety Suite, a platform containing applications that allow the management of the drug safety lifecycle, including case intake and adverse event processing as well as authoring and regulatory submissions.
The suite already contains Vault Safety and Vault SafetyDocs and will now be expanded with Vault Safety.AI, an artificial intelligence (AI) application that automates case intake, which will be available in April 2020.
Safety.AI automatically converts text input from sources including social media, fax, email, literature, and call center notes and fills the required fields in a drug safety case, according to the company. These fields include patient information, adverse events, medical history, products, and reporter information.
The purpose of the application, according to Veeva, is to enable pharmacovigilance organizations to reduce the time to enter and verify a case, as well as to achieve better scale operations as case volume increases.
“The high cost and manual effort of case intake processes are no longer sustainable, making it an area that is ripe for innovation,” Brian Longo, senior vice president and general manager, Veeva Vault Safety, said in a statement.
Asked about the advantages of Safety.AI compared to other existing similar applications, Longo told us that that existing solutions are not well integrated with the safety applications, requiring companies to install and integrate multiple applications to manage drug safety.
“As regulations change or there are new software releases, companies need to upgrade one or multiple software components, test them, and ensure they work together,” Longo added.
According to Longo, as part of the Veeva Vault Safety Suite, Safety.AI “is the only comprehensive cloud solution to manage the end-to-end drug safety lifecycle. Built on the same cloud platform, Safety.AI has access to more data to continually learn and improve.”
For example, Longo told us that as an adverse event is processed, information at different decision points in the pharmacovigilance lifecycle, like drug role classification, can be fed to the AI engine to ‘significantly’ improve future safety cases.
Safety.AI will also have the ability to connect to existing safety databases for processing and submissions, while it will also have a public API that can integrate with external data sources for adverse event reports.
Vault Safety Suite is part of Veeva Development Cloud, a broader platform that includes software services for clinical data management, operations, quality, and regulatory processes.