Report Trial/Study PV Cases

Innovative pharmaceuticals, besides authorized products, have a huge pipeline of investigational drugs in different phases of clinical trials. These investigational products pose a significant challenge for Clinical Pharmacovigilance.

Pharmacovigilance in clinical trials is the monitoring of the serious adverse events that occur to the participating patients in a trial. Patient safety in clinical trials needs continuous monitoring. All adverse events are documented whether they are considered related or not to the study drug. Safety information from clinical studies is used to establish a drug’s safety profile in humans and is a key component that drug regulatory authorities consider in the decision-making as to whether to grant or deny market authorization (market approval) for a drug.

PvEdge offers a specific clinical trial pharmacovigilance functionality to handle life cycle risk-benefit management of medicinal products. PvEdge ensures better risk-benefit profiling of New Chemical Entities (NCEs), Investigational New Drugs (INDs) and new drugs on the market with functionalities facilitating early signal detections.

  • Clinical Trial Study Details; related info like sites and investigators involved
  • Clinical Trial Project specific Investigational Medicinal Product (IMP) creation
  • Reporting rules based on trial specific details; triggering auto scheduling of reports to regulatory authorities and ECs
  • Allows a case processing of open label study and blinded study
  • Generate Line Listings and event Tabulations as per Annual Safety Reports (ASR) requirements
  • Early signal detection in clinical projects; screening relevant ICSRs with automated data mining tools
  • Easy case processing, with auto-update of fields based on already fed information
  • Capture causality assessment of both investigator and sponsor

PvEdge also provides functionality for Ethics Committees to process SAE’s and generate CDSCO (Central Drugs Standard Control Organization) reports.

  • Inbuilt Annexure XI form
  • System generated Mail and/or SMS alerts once Ethics Committee receive SAE
  • Customized workflow
  • Facility to shoot out mails to all Ethics Committee members
  • Voting option to Ethics Committee members for individual case