Digitalize and Automate Literature Screening while increasing efficiency and achieving compliance
According to GVP Module VI, every Marketing Authorization Holder (MAH) should have a dedicated Literature Monitoring program as part of safety monitoring of medicinal products to regularly search for articles in the literature databases and report adverse events. Non-compliance to this requirement may result in challenges like missing relevant ICSRs, inadequate aggregate reporting, missing safety signals and a major audit finding leading to withdrawal of the drug from the market.
PVSentinel Literature Screening
Key Solution Capabilities
Import Literature Articles
Integrate with online databases such as Medline, Ovid, Embase, etc. or manually add unpublished articles presented at different forums.
Perform duplicate check against all the existing records processed and avoid duplication of the articles in the system
Screening of Articles
Automated screening of articles by AI and NL, for identification of data points in the articles for final review.
Define Lifecycle Management Workflows
Enforce business workflows specific to your requirements, SOPs, and global regulations
Correspondence for Additional Requests
Manage all email communications and request full text and translations for the articles directly from the system
Integration with Safety System
Transmit ICSR relevant articles to a safety system with all relevant data points and abstract, full text and translated articles as attachments. PVSentinel has a built out-of-the box integration connectivity with Oracle Argus Safety.
Alerts and Notifications
Streamline the process by receiving alerts & notifications and adhering to timelines of submissions making the system compliant, productive and efficient.
Literature Monitoring through Insights
See and manage the articles at every aspect of the process through standard reports and dashboards
How Do we Deliver
PVSentinel Literature Screening module is a component of our PVSentinel platform. It can be deployed on its own or in combination with other modules of the platform.