Corpus Application

Corpus Application Suite® is a proprietary solution offered by Sophos to meet all aggregate regulatory and internal reporting needs. Developed using advanced technology, Corpus Analytics® enables the user to query, analyze, monitor safety data and also complements with the reports that are not available in Safety System.
Corpus Analytics

Corpus Analytics

  • A plug and play solution compatible with Argus Safety Transactional, DLP, Argus Mart and Argus Insight
  • Interactive screens for analyzing and monitoring safety data
  • Report generation on point-in time data
  • Ad-hoc reporting
    • A simple drag and drop (select/unselect) functionality for non-technical users to develop reports
    • Pre-configured templates for standard formatting and look & feel
  • Report configuration
  • Report scheduling
    • Email
    • Alerts

 

Corpus Reports

Corpus Reports Library

Corpus Analytics® comes with a reports library that consists of 40+ Out-Of-Box pre-configured customizable reports designed to meet 90–100% PV reporting needs. Various reports in report library are categorized as follows:

  • Regulatory Reports (PSUR, DSUR, PBRER etc.)
  • Supporting Aggregate Reports
  • Line Listings
  • Linked Cases (Pregnancy and Lactation)
  • Lot Manufacturer (Vaccine Reports)
  • Device Reports
Corpus Compliance Monitor

Corpus Compliance Monitor

  • Inspection readiness
  • Case processing matrices
  • Prospective and Retrospective Compliance Dashboards
  • Case tracking in workflow
  • Tracking of delays and potential delays
  • Capture and track reasons for lateness
  • Assign and track action items
  • Create, assign and track CAPAs

 

Corpus Signal

Corpus Signals

  • Safety profile tool for
    • Line listings
    • Tabulations
    • Charts and graphs
    • Drill-down, slice and dice
    • Comparison/analysis of pre and post authorization data
  • Data mining
    • In-house safety system
    • FAERS, VAERS and Vigibase
    • WHO-UMC
  • Trend analysis
    • Spike analysis
  • Reports
    • Reaction monitoring reports
    • PRR (Proportional Reporting Ratio)
    • Benefit-risk reports (Indication vs Reactions)
    • Patient demographics
    • Drug-drug, drug-disease interaction
    • Overdose, abuse, misuse, medication error
Corpus Topics

Corpus Topics

  • Workflow
    • Create assign and review topic
    • Create and assign action items
    • Annotation, tag (keywords) single or multiple cases
    • Add attachments
  • History and audit trail
  • Reports
    • Search on topic or keywords
    • Generate and review the listings, tabulations, charts and graphs
    • Single case review

 

Corpus Risk

Corpus Risk Management Module

  • Develop and maintain RMP and Pharmacovigilance Plan
  • Analyze safety data with RMP
  • Safety signal evaluation
    • Ad-hoc
    • Periodic
  • Medical Monitoring
  • Risk benefit assessment
    • Identified risks
    • Potential risks
    • Causality assessment

 

CAPA

Corpus CAPA Vigilance

  • Create/Initiate CAPAs
  • CAPA workflow
  • Assign/re-assign
  • Attach case list
  • Add user story
  • Attach documents
  • Audit trail