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Automated literature surveillance

An automated platform for all the end to end literature monitoring activities which covers wide range of medical and scientific journals in many languages from many countries

The medical literature monitoring (MLM) is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. Hence, it is important to review suspected adverse reaction gathered from scientific journals, medical researcher, relevant published abstract and draft manuscripts.

Marketing authorization holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Pubmed, Medline, Excerpta Medica or Embase) no less frequently than once a week.

In addition, marketing authorization holders should have procedures in place to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorization, and to bring them to the attention of the company safety department as appropriate.

The expense and efforts required to obtain important safety information from the vast amount of published literature in many languages and countries of the world is a rather challenging task.

Why PvEdge?

PvEdge Literature Module offers an automated platform for all the end to end literature monitoring activities which covers wide range of medical and scientific journals in many languages from many countries. PvEdge built on industry best practic which allows MAH to have an integration with EVWEB with various “Reports” criteria items to filter down the results of a bulk ISCR requests like;

  • PV obligations reports (L2A)
  • Case narrative requests (L2B)
  • MLM reports
  • PV obligations reports (L2A) & MLM reports.

Operational efficiency

PvEdge helps users by collecting all product specific literature, scrutinizing duplicates, managing and monitoring full-text requisitions, classify MAH ICSR and documenting all selections and rejections electronically.

Functional efficiency

  • Greatly improves productivity with enhanced transparency
  • Filtering of safety publications into selected, non-selected, article of interests for PSUR and signal detection
  • Inbuilt integrated workflow wherein Medics review all the selections made by preliminary assessors for the final evaluation for validity of ICSRs
  • 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.
  • Any status can be searched, and articles filtered!
  • Usually weekly search is performed
  • Full text can be transferred in case
  • Full text can be archived and attached
  • Currently configured to PubMed