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PVSentinel Literature Screening

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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

Automate Literature Screening using Artificial Intelligence

  • Use AI to screen Abstracts, Full Texts and Translated articles to categorize the literature article and identify patients, authors, events, products and  safety related information.
  • Perform user reviews on identified information to accept, reject or add additional data points and submit articles for secondary reviews

Configurable Workflows for Efficiency in Monitoring and Reporting

  • Digitally track the complete Lifecycle of Literature monitoring from initial review to ICSR intake in a Safety System
  • The established integration of PVSentinel with literature databases such as Medline, Embase, etc. eliminates manual search complexities and reduces overall resource effort

Achieve Regulatory Compliance and Stay Audit Ready

  • Perform the complete literature monitoring and screening process within the system with audit trail for all activities performed
  • Complete review tasks in a given time to be regulatory compliant
  • Generate reports to get insights on outcomes and operations

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 or manually add   unpublished articles presented at different forums.

Duplicate Check

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.

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