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.
How Compier Literature Screening Can Help Your Organization
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 or manually add unpublished articles presented at different forums.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
Request Full Texts and Perform Online Translations
Communicate with third party vendors or integrate with third party tools for obtaining Full Texts and leverage built-in Translation capabilities for different articles
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. Compier 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
Compier Literature Screening module is a component of our Compier platform. It can be deployed on its own or in combination with other modules of the platform.