Safety Literature Monitoring

ADRium™ Literature enhances pharmacovigilance and compliance by automating the retrieval and review of scientific literature. This platform ensures accurate and efficient analysis while meeting regulatory standards, improving operational efficiency.

Optimize literature monitoring with advanced compliance and efficiency

ADRium™ Literature simplifies the review of scientific literature with advanced automation. Our platform provides efficient article management and comprehensive reviews, ensuring regulatory adherence. The examples below explore how clients have leveraged ADRium™ Literature to improve literature monitoring and data accuracy.

Streamline the handling and review of scientific literature

  • Automatically import articles to minimize manual entry
  • Select articles for ICSR, aggregate reports, and signal detection
  • Retrieve full-text articles for in-depth reviews

Ensure ease of use and configurability for staff

  • Utilize an intuitive platform for seamless navigation
  • Configure settings to meet specific review needs
  • Manage review due dates with automated alerts

Enhance accuracy and thoroughness in literature analysis

  • Perform end-to-end literature reviews with automated batch runs
  • Retrieve and include reviewed articles in aggregate and ad-hoc reports
  • Access detailed administrative controls and user audit trails

Maintain oversight and meet compliance standards

  • Use administrative controls for effective management
  • Track user activity with detailed audit trails
  • Ensure compliance with regulatory requirements through streamlined processes

why synapmed?

Synapmed’s ADRium™ Literature capability within our ADRium™ solutions suite and PVaaS platform streamlines literature monitoring with automated retrieval and analysis of scientific data. Our safety literature monitoring technology provides timely and accurate reviews while ensuring regulatory compliance. With user-friendly features and customizable automated workflows, Synapmed helps you efficiently manage literature for ICSR, aggregate reports, and signal detection, allowing you to focus on developing safe and effective products.

Frequently asked questions

What is safety literature monitoring?
Safety literature monitoring involves reviewing scientific articles and publications to identify relevant safety information related to drug products. It helps ensure that new safety data is incorporated into pharmacovigilance systems and regulatory reports.
Automating literature retrieval is important because it reduces manual effort, speeds up the review process, and minimizes the risk of missing relevant safety information. Automation ensures that literature is efficiently gathered and reviewed, improving accuracy and compliance.
A literature monitoring tool improves efficiency by automating the retrieval and review of scientific articles. It streamlines article management, provides user-friendly interfaces, and integrates with existing systems to enhance the speed and accuracy of literature reviews.
Comprehensive review processes systematically evaluate scientific articles to extract relevant safety information. This includes importing full-text articles, conducting thorough reviews, and including findings in regulatory reports and signal detection.
A literature monitoring tool ensures regulatory compliance by automating processes to meet regulatory standards, providing detailed audit trails, and offering administrative controls to track user activity. It helps maintain oversight and ensures all literature reviews adhere to regulatory requirements.

ADRium™ Literature is a capability within our ADRium™ solution suite and PVaaS platform developed by Synapmed designed to enhance pharmacovigilance through automated retrieval and analysis of scientific literature. It supports safety literature monitoring by providing efficient article management, a user-friendly interface, and a comprehensive review process. The platform ensures accurate and timely reviews, regulatory compliance, and improved operational efficiency with features like automated batch runs and detailed administrative controls.

Pharmacovigilance — Should You Outsource?

Navigating pharmacovigilance presents substantial challenges for life sciences companies, especially when interpreting the finer points of compliance. Failure to meet these stringent requirements can lead to severe consequences, including inspections or even revocation of marketing authorization. Companies face a critical decision: should they manage pharmacovigilance operations in-house or outsource to specialized firms? Each option has its own set of advantages and drawbacks, and understanding these is key to maintaining compliance and ensuring the safety of products on the market.

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No matter the size or scope of your projects, you have a committed partnership team with Synapmed. We’re a team that listens, pays attention to details, and brings smart insights to the table. We do it all so you can solve real problems throughout the product development and commercialization lifecycle.