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 |
There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.
I just wanted to let you know that the recent EU Codes webinar was excellent. Rina presented a very complex and grey topic in the most clear and digestible manner – a sign of a true expert. The questions in the Q&A were sometimes a little ambiguous but Rina gave clear and relevant answers that provided real clarity.
