Literature Monitoring
Literature screening in pharmacovigilance is a critical process that involves searching, retrieving, and evaluating information from various sources to identify potential safety concerns with a drug or medical device. It is a systematic and ongoing process of searching, reviewing, and analyzing published literature and other sources of information for potential adverse drug reactions, new safety concerns, and other relevant pharmacovigilance information. This information is used to identify potential signals of harm and support drug safety decision-making.
Literature monitoring is an important component of pharmacovigilance, as it helps ensure that the latest safety information is incorporated into the benefit-risk assessment of marketed drugs.
With over 15+ years experience, Our highly specialized PV team can help marketing authorization holders to conduct medical literature surveillance at least weekly according to the GVP module VI and based on the required frequency as described by the local regulatory authorities, both for globally indexed literature databases and locally (non-indexed) literature journals.
How We Can Help
- Perform comprehensive literature search across medical publications, scientific journals, and biomedical databases (Medline, PubMed, Embase, etc.)
- Develop and implement robust search strategies after completing sensitivity testing to ensure that search criteria are robust and accurate for each product
- Using our proprietary Compier Literature Screening AI application, we can complete rapid article search, extract information from abstracts and retain historical records
- We have a well-established deduplication system to avoid missing relevant references or creating duplicate ISCRs inadvertently
- Our PV experts can conduct literature searches and evaluate the results for literature per regional requirements (Global and Local).
- We always strive towards meeting timelines and avoiding delays in communicating and reporting to regulatory bodies.
