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.
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.
| Automated Global and Local Literature surveillance (PubMed and non-indexed journals) | Understanding of full text articles and case processing (ICSRs) | Medical assessment and classification of literature references |
| Generate information search strategies with high recall and precision | Quality Review on sample of screened abstracts and articles | 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 |
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Integration of Medical Literature Monitoring (MLM) service
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Increased PV search efficiency and accuracy via AI enabled <<< Literature Management Tool – SmartVigilit® >>> | Case reports (ICSRs) in CIOMS I or E2B-compatible (R2 & R3) format with automated communications via email notifications |
| Duplicate check performed for all case reports against cases provided by MLM (EMA) | Full text articles purchasing | Translation for foreign language articles |
Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!
We really appreciate your responsiveness and availability during our previous exchanges and it is what we are waiting for from our partner.
Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.
