Medical Literature Monitoring Services
Medical literature, including literature review in research, is one of the primary sources of safety data. As regulations become increasingly stringent MAHs are presented with challenges in incorporating safety data into their pharmacovigilance practices for compliance. Therefore, regular monitoring of scientific literature is key for timely identification of ICSRs that not only helps in fulfilling the safety compliance, but also helps in including the relevant safety information in aggregate reports for timely completion and in identifying the signals. Drawbacks or errors in these processes can negatively affect the pharmacovigilance compliance by MAH & may lead to adverse audit/inspection findings.
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:
- Weekly monitoring of publications in different databases such as Embase, PubMed or Medline
- Weekly monitoring of non-indexed literature, including journals, on local databases for target countries in local language
- Weekly monitoring of ICSRs received as through Medical Literature Monitoring (MLM) or Anonymized Single Patient Reports (ASPRs)
- Devising comprehensive literature search strategy for weekly outcome from PubMED &/or EMBASE
- Documentation of outcomes using abstract or full text articles that assist in identifying ICSRs ,
- Maintaining the complete tracking of literature cases based on Validity,
- Use in Aggregate reports and PSUR/ RMP
- Use in identifying the signals
Basics of Literature Monitoring in Pharmacovigilance
Literature monitoring is a critical component in pharmacovigilance. It is a systematic process of reviewing medical and scientific literature, journals, and other relevant sources. Frequent monitoring of these sources helps to identify information related to adverse effects, drug safety issues, and any emerging risks that are associated with drugs. Literature monitoring in pharmacovigilance supports traditional pharmacovigilance activities and provides valuable and more holistic safety insights to the drug’s safety profile. Essential components of literature monitoring include searches on global literature databases, data extraction, signal detection, causality assessment, integration with other data sources, and more.
DDReg’s services in medical and scientific literature monitoring constitute systematic tracking and the analysis of journals, clinical studies, and other relevant publications with the aim to identify emerging safety signals for pharmaceutical products. The team leverages their technical expertise in reviewing publications and access to indexed & non-indexed literature databases to provide crucial insight to enhance regulatory compliance and patient safety.
Literature monitoring is an indispensable pillar in pharmacovigilance as it offers a proactive lens into the dynamic landscape of pharmacovigilance. Its capacity to provide valuable insight from publications, capturing real-word drug experiences, and identifying emerging risks that would not be detected in clinical trials helps to truly encompass the safety profile of a drug. Indeed, in the dynamic realm of pharmacovigilance and post-market safety surveillance, literature monitoring is an essential tool in order to safeguard public health.