Intuitive Reports. Superior Risk Mitigation.

Based on our extensive pharmacovigilance operations experience, we customize database software query tools to expand your data mining capabilities. To make the compliance process easier and more efficient, our solution performs signal detection activities and identifies trends to help mitigate your product’s long-term risk. Access the data you need to answer critical safety questions and gain a context to illuminate whether issues are isolated or systemic.

Our intelligence tools include:

  • Periodic benefit-risk evaluation reports (PBRER)
  • Development safety update reports (DSUR)
  • Clinical data and product complaint reconciliation reports
  • Signal detection listings, tabulations and dashboards
  • Workflow and operational productivity and compliance metrics
  • Auto-scheduled recurring reports delivered to target audiences at predetermined intervals
  • Ad hoc reports with quick turnaround
  • Experience with various reporting tools including comprehensive visualization of compliance and metrics data via Oracle Business Intelligence Enterprise Edition (OBIEE) dashboards, notifications and alerts
  • Rigorous report validation process that ensures all analytic deliverables have been validated via suitable mechanism per intended business use