Overview

Pharmacovigilance safety database systems are crucial in today’s Life Sciences world. The safety database acts as a repository for all the Individual Case Study Reports (ICSRs) collected for every sponsor medicinal product. The safety and pharmacovigilance database should be compliant with the latest Regulatory requirements and is validated to meet various standards.

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

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

The safety and pharmacovigilance all-in-one system allows Freyr to set up and maintain a 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. It also saves considerable costs in implementation, maintenance, and upgradation. Freyr provides separate safety database instances to ensure the 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
  • 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, Upgradation, and Maintenance
  • Legacy Safety Database Migration
  • Electronic Gateway Profile Creation Services
  • EV Web/FDA Web Trader Account Creation
  • E2B R2 to R3 BFC Support