Literature Monitoring & Screening

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.

 

Our Solution offers:

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
Integration of Medical Literature Monitoring (MLM) service	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