Overview

Pharmacovigilance safety database systems are key in today’s Life Sciences world. The Safety database acts as repository for all the ICSR collected for every sponsor medicinal product. The Safety database should be compliant with the latest Regulatory requirements and is validated to meet various standards.

Safety database is heart of the PV activities such as Individual and aggregate safety reporting obligations of the sponsor. The key elements of aggregate reports, signal detection, risk mitigation activities are derived from safety database.

Freyr provides a fully managed and maintained safety database solution with Clinevo Safety Database Software.

is a cloud-based, user-friendly, easy to use, Regulatory compliant end-to-end Pharmacovigilance/Drug safety system. The all-in-one system provides PV Intake, Case Processing, Regulatory Submissions/AS2 Gateway, Analytics and Safety Signals Capabilities under one platform.

This all-in-one system allows Freyr to set up and maintain a Safety database that is validated and Regulatory compliant at a very competitive cost. The Safety database is upgraded frequently as per the internal guidelines without much downtime. The Safety database solutions also saves considerable cost in implementation, maintenance, and upgradation. Freyr provides separate safety database instance to ensure confidentiality of data.

Salient Features:

  • Transparent optimized pricing with no compromise in functionality
  • Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR inspection ready.
  • One solution to handle PV Intake, case processing, submissions, AI & analytics, and safety signals.
  • Easily configurable dynamic workflows for expedited case processing
  • Database provides powerful and actionable insights
  • Advanced automation and AI features

Our Solution Approach:

End–to-end ICSR case processing activities bundled with the PV Safety database.

PV Safety database services (hosting, servers, implementation, upgradation, maintenance, and Support).

 

Freyr Expertise

  • MedDRA & WHO DD License, Upgrade and Maintenance
  • Legacy Safety Database Migration
  • Electronic Gateway Profile Creation Services
  • EV web/FDA Web Trader Account Creation
  • E2B R2 to R3 BFC Support