Our experts turn complexity into clarity - so you can focus on innovation while we safeguard your patients and your product.

At the heart of our pharmacovigilance services is a robust, expertly managed case processing framework designed to uphold the highest standards of patient safety and regulatory compliance. We manage the end-to-end processing of Individual Case Safety Reports (ICSRs) and maintain comprehensive records of adverse events - globally for clinical trials and post-marketing safety programs.

We offer specialised expertise for companies transitioning to first approval or post-approval programs, ensuring a smooth and compliant journey.

Implementation & Onboarding
  • Process mapping and SOP development
  • Safety database configuration and system setup
  • Training and knowledge transfer
  • Test case execution to validate system functionality
  • Seamless client onboarding
Program Management
  • Primary point of contact for all PV activities
  • Liaison between internal and external teams
  • Timeline and deliverable management
  • Coordination of audits and inspections
Reporting & Metrics
  • Monthly reporting of key metrics and case volumes
  • Signal detection and follow-up actions
  • Dashboards, KPIs, and narrative summaries tailored to stakeholder needs
Compliance & Oversight
  • Regular reviews of compliance, risk, and performance
  • Adherence to global and local PV regulations
  • Periodic internal audits and deviation tracking
  • Inspection readiness and compliance monitoring
Cross-Functional Collaboration
  • Maintain inspection readiness and compliance
  • Risk communication and assessment coordination
  • System integrity and data migration assurance
  • Reporting alignment and reconciliation
  • Protocol compliance
Global and Local Literature Search Administration
  • Development and maintenance of literature plans
  • Search strategy, frequency, and source selection
  • Documentation of search results and compliance tracking