Literature Automation

Reports of suspected adverse reactions from the scientific and medical literature, including relevant published abstracts from meetings and draft manuscripts, should be reviewed and assessed by marketing authorization holders to identify and record ICSRs originating from spontaneous reports or non-interventional post-authorization studies.

The pharmaceutical company has to identify reports of adverse reactions published in the medical and scientific literature (by a process of weekly “literature screening”) and cases must be reported by the company in a similar way to the regulatory authorities. The expense and efforts required to obtain important pharmacovigilance information from the vast amount of published literature in many languages and countries of the world is a rather challenging task.

PvEdge by collating all drug-specific literature hits, scrutinizing duplicates, managing and monitoring full-text requisitions and documenting all selections and rejections electronically, greatly improves productivity, with enhanced transparency.

  • Filtering of safety publications into selected, non-selected, article of interests for PSUR and signal detection
  • Inbuilt workflow wherein Medics review all the selections made by preliminary assessors
  • Seamless case creation for approved literature reports with unique case IDs
  • Complete audit trail along with assigned justifications
  • Retain records to enable retrieval throughout the records retention period