Veranex

Exhibitor- Veranex

Veranex Data Management & Analytics offers Database Programming, Data Management, Biometrics, Pharmacovigilance, Medical Writing and Regulatory Publishing, and Centralized Monitoring. Veranex's reliable, global Data Management Ecosystem ensures a high-quality deliverable and superior value. CROs, big pharma, biotech companies, and medtech companies trust Veranex to be their data management and analytics partners

We provide a comprehensive set of Pharmacovigilance and Postmarket Surveillance services.

• Case processing (clinical and postmarketing)
• Aggregate reports
• Literature screening
• Signal detection
• QPPV services
• Safety database hosting
• All other documentational logistics

Safety management plan (SMP)
• Custom creation and templates for internal and external safety communication
• Support for implementation and coordination
• Comprehensive safety protocols for each study activity
• Definition of roles and responsibilities for entire safety management process
• Organization of an efficient workflow

SAE collection and reporting
• Definition of SAE procedures for each study
• SAE collection, evaluation, causality assessments and reporting
• Formation of E2B transport file for SAE integrations from the EDC system
• Safety database entry
• Signal detection
• Clinical and postmarketing case processing
• Medical accuracy evaluation
• CRF-compliant coding
• Reporting, including aggregate reports and allapplicable reports for drugs, biologics, and devices
• Screening of the literature
• Qualified Person Responsible For Pharmacovigilance (QPPV) services
• Global PV audits

Safety database
• Safety database hosting and data maintenance
• Creation of safety database independent from the clinical trial database
• Custom database setup (Argus, ArisG, Sceptre, AB Cube) per the study protocol
• Recording and organization of all data received by the safety department
• Reconciliation of safety data with clinical adverse event data
• Collaboration with our data management team or client’s data management team

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