Faster and Easier Literature Review to Case Intake

Oct 16, 2025 | Christina Kim and Celine Ghafari

This edition of Veeva’s Safety Newsletter covers literature review, a significant source of individual safety case reports (ICSRs). Learn how automation and an integrated safety system can greatly reduce manual effort, as well as compliance and patient safety risks.

33% of ICSRs come from literature review

Approximately one-third of individual safety case reports (ICSRs) are sourced from scientific literature, according to a 2020 study by the NIH. Market authorization holders (MAHs) have an obligation to monitor medical literature for ICSRs or emerging safety information (signals).

But the process can be time-consuming and labor intensive, with an estimated 1,500-3,000 article reviews a week for large global biopharmas. For smaller biopharmas, this process may be outsourced, creating data and operational silos. Common challenges include:

• Scaling high volumes of literature review from a wide range of sources
• Manual data capture across systems when ICSRs and signals are detected
• Misalignment or missed data between in-house teams and outsourcing partners who are responsible for a portion of the process (e.g., case processing vs. literature review)

Inefficient and manual literature review processes create compliance and patient safety risks.

Streamline case intake for faster ICSR reporting

Safety teams can streamline the literature review process by enabling bulk literature article intake, from sources like PubMed, to greatly reduce administrative overhead manually aggregating articles. When reviewers identify ICSRs, integrating the literature review process with your safety system allows them to seamlessly create a safety inbox item for case processing with just a few clicks.

Seamless literature review and case processing:

• Simplifies the literature review to case intake process
• Enables seamless transfer of literature data to the safety inbox item
• Supports traceability of ICSRs back to the literature source
• Reduces manual data entry and reconciliation

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