Clinical ICSR
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Clinical ICSR

A complete life cycle management of clinical ICSRs safety reporting for better risk-benefit profiling of New Chemical Entities (NCEs)/Investigational New Drugs (INDs)

Clinical safety concerns with the collection, processing, and analysis of adverse event reports from investigators using the product in the tightly controlled setting of clinical research design.

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 a 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.

Why PvEdge?

PvEdge offers a specific clinical trial pharmacovigilance functionality to handle complete life cycle of clinical ICSRs. PvEdge ensures better risk-benefit profiling of New Chemical Entities (NCEs)/Investigational New Drugs (INDs) which are under pipeline for regulatory approval, which facilitates early signal detections before the marketing approval of the investigational product. Following objectives can be achieved.

Configurational and functional objectives

  • Pre-configuration of clinical trial study protocol in the database from back end is not required as a privilege user can add any study, investigator, and investigational product related information (IMP creation) from front end in the live environment in the database, which can be seeminglessly retrieved while processing the clinical ICSRs
  • Accurate assessments of clinical SUSARs (suspected unexpected serious adverse reactions) through the event assessment section in the database which is fully compliant for regulatory reporting of all the clinical ICSRs including serious/NS ICSRs and SUSARs
  • Demonstrating an adequate and compliant causality assessment procedure while completing the case processing for clinical trials
  • Reporting rules are based on trial specific details; which triggers auto scheduling of regulatory reports with regards to event assessments from investigators and further submitted to concerned regulatory authorities and ethics committees on time
  • Generating clinical trial line listings and event tabulations as per Annual Safety Reports (ASR) requirements in preparations of DSURs (developmental safety reports) as PvEdge keeps detailed records of all clinical trial related data including regulatory submissions which can be reviewed on request by regulators during client audits/inspections
  • Providing functionality for Ethics Committees to process SAE’s and generate CDSCO (Central Drugs Standard Control Organization) reports

Operational objectives

  • PvEdge is strictly compliant with the regulatory timelines for reporting of Clinical ICSRs which involves reporting of clinical SUSARs to regulators within 7 calendar days if they are classified as fatal or life-threatening. Those which are non-fatal, non-life-threatening were reported within 15 calendar days
  • PvEdge allows case processing of ICSRs for open label studies and blinded studies
  • Allows early signal detection in clinical projects; screening relevant ICSRs with automated data mining tools
  • Provides user-friendly database environment for all users (Data entry, QC users, and Medics), with auto-update of fields based on already fed information
  • Clients achieve full E2B (R3) compliance with regulations from ICH, US FDA, EMA and PMDA, including all regional variations
  • Provides customized workflow and routing pattern as per client’s practice (Client specific workflows in clinical trial cases)
  • Facility to shoot out emails to all Ethics Committee members and investigator sites as and when required