Literature Surveillance

PharmaLex recognizes that medical and scientific literature emerges as a critical information source for benefit-risk evaluation of medicinal products. PharmaLex offers a modular, end-to-end approach to literature surveillance for pharmacovigilance and our experts are flexible enough to offer a tailored solution as well accordingly to client’s requirement.

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    Literature Monitoring & Screening

    Global (Indexed) & Local (Non-Indexed) literature surveillance becomes an integral aspect in pharmacovigilance as the main objective of the screening is to identify case reports (ICSRs) and/or any substantially new information from studies (epidemiological, clinical, and non-clinical) pertaining to safety and efficacy. Literature search and review is therefore a critical activity that we undertake for the safety profiling of drugs.

    We offer global solutions covering the entire product lifecycle

     Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.

    Our Solution offers:

    • Automated Global and Local Literature surveillance (PubMed and non-indexed journals)
    • Generate information search strategies with high recall and precision
    • Integration of Medical Literature Monitoring (MLM) service

    • Duplicate check performed for all case reports against cases provided by MLM (EMA)
    • Understanding of full text articles and case processing (ICSRs)
    • Quality Review on sample of screened abstracts and articles
    • Increased PV search efficiency and accuracy via AI enabled  Literature Management Tool – SmartVigilit® 
    • Full text articles purchasing
    • Medical assessment and classification of literature references
    • Archival & retrieval of abstracts for PV processes e.g., Signal Detection and PSUR(s)/PBRER(s) preparation and benefit-risk evaluation (BRE) of Medicinal Products
    • Case reports (ICSRs) in CIOMS I or E2B-compatible (R2 & R3) format with automated communications via email notifications
    • Translation for foreign language articles

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