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Pharmacovigilance

Ensuring patient safety

Led by industry safety experts, UBC combines a depth of experience in safety/pharmacovigilance, risk management, signal detection, and assessment with the newest and most innovative technology systems.

Services:
  • Safety Database Hosting
  • Literature Screening
  • Risk Management
  • Case Processing (for clinical trials, post-marketing studies, & spontaneous reports)
  • Signal Detection and Assessment
  • Safety Writing (aggregate reports)
  • European Services (QPPV/ Local QP, PSMF, Regulatory Registration, MAA Support)

UBC Technology – Automated Software Suite

UBC has always operated on the principle that patient safety is a critical industry responsibility. Our people bring a depth of understanding to the complex and rapidly evolving landscape of safety that cannot be matched or replaced by any technology on the horizon today. UBC’s technology roadmap for PV focuses on tooling that streamlines and simplifies core workflows and maximizes the value these experts bring to the industry.

SPONTANEOUS REPORT DATA

UBC Technology | PVPlan

PVPlan

PVPlan™ for pharmacovigilance (PV) teams allows users to track and manage product safety concerns. PVPlan automates both the day-to-day and overall management of this critical component in drug safety to ensure timely, accurate, and auditable assessment of safety signals.

PVPlan has an easy-to-use, point-and-click interface with the real features a PV team needs including email alerts, team performance reports, and regulatory reporting such as for the European Medicines Agency (EMA) Emerging Safety Issue (ESI) requirements or the FDA’s PBRER.

PVPlan puts the efforts of your safety scientists and safety physicians where they belong, on detection and risk identification, while reducing paperwork and generating a full audit trail.

UBC Technology | CLÆRITY®

CLÆRITY®

CLÆRITY® offers simple, intuitive software for analysis of spontaneous reporting databases using state-of-the-art calculations for disproportionality analysis, including Pvmaps™, PRR, and MGPS. Users can perform data mining in multiple sources, including FAERS, EudraVigilance eRMRs, Vigibase, Canadian data, and client sources; track trends; and analyze the effects of possible drug interactions and comorbidities in the reporting population.

Data Driven

We generate high-quality reports to keep you informed.

65k

Reports processed in Argus or other PV database/yr.

98%

PV client satisfaction rate

30+

Regulatory inspections, 0 critical findings

99%

On-time regulatory submission compliance

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Safety & Risk Management Services