Literature Monitoring Services

Advanced Pharmacovigilance Literature Screening for Drug Safety

In pharmacovigilance, medical literature monitoring is an essential tool for identifying critical safety data. As regulations become stringent, Marketing Authorization Holders (MAHs) face increasing challenges to integrate this data into their pharmacovigilance practices, ensuring full compliance. Consistent pharmacovigilance literature monitoring is key to promptly detecting Individual Case Safety Reports (ICSRs), which not only helps meet regulatory requirements but also guarantees relevant safety information is incorporated into aggregate reports. Automated literature monitoring, driven by artificial intelligence (AI) tools, helps in making medical literature monitoring more efficient, saving on time. This timely approach aids in signal detection and fosters compliance. Neglecting these processes, however, can result in costly errors or gaps in reporting, leading to adverse audit or inspection findings that could harm the MAH’s standing. Regular literature review isn’t just a regulatory necessity; it’s a proactive strategy to protect patient safety and maintain regulatory excellence.

DDReg offers specialized and comprehensive literature monitoring and surveillance services to organizations. The literature monitoring team understands the crucial role that medical and scientific literature plays in providing a source of important information for the benefit-risk assessment of pharmaceutical and allied products. Our team works to ensure that there is no compromise in identifying & processing the literature ICSRs and/or safety signals DDReg literature surveillance team has expertise in devising comprehensive search strategies, carrying out review of weekly outcomes from global (indexed) literature databases such as PubMED or EMBASE,local (non-indexed) literature, and triaging & booking the cases that are identified.The team also performs duplicate checks and quality review on cases, abstracts, and articles.

DDReg’s Literature Monitoring expertise includes: