Literature Automation

Generic Pharmaceutical companies are in unique position with their large basket of active moieties, for which as per regulatory mandate, performing global literature surveillance becomes a very tedious and time consuming task.

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 authorisation holders to identify and record ICSRs originating from spontaneous reports or non-interventional post-authorisation 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.

PvEdge with its exclusive and highly beneficial Literature automation automates Global literature surveillance activities. Published medical literature is a well-recognized and valuable source of medical information. It is a colossal task to monitor and track all the world’s medical literature for drug safety information.

The expense and efforts required to obtain important pharmacovigilance information from the vast amount of published literature in many languages and countries of world is a rather challenging task. Duplicate reports are always a challenge as the same reports may be published in different journals, republished in review articles or could be a duplicate of a spontaneous report.

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

  • This is an exclusive and highly beneficial module that automates Global literature surveillance activities
  • Filtering of safety publications into selected, non-selected, article of interests for PSUR and signal detection
  • In built 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 records retention period