Oracle Health Sciences Empirica Trace

Oracle Health Sciences Empirica Trace software helps small, medium, and large biopharmas, medical device manufacturers, and clinical research organizations collect, code, analyze, and report adverse events as well as meet regulatory reporting deadlines and global requirements.

The Oracle Health Sciences Empirica Trace safety database is complemented by a configurable query engine, a full range of status and productivity reports, and an integrated visual reporting environment. Additional tools may be licensed to support signal detection and analysis, signal management, and clinical trials signal detection.

Additionally, Oracle Health Sciences Empirica Gateway software offers expanded submissions tracking and acknowledgements through integration with Oracle Health Sciences Empirica Trace and enhanced application security. It streamlines the exchange of electronic case safety information with regulatory agencies, affiliate offices and trading partners and is designed to adhere to specifications established by ICH, EMEA, MHLW and FDA, including the FDA's latest Electronic Submission Gateway (ESG) standards.

BENEFITS

  • Speeds information delivery, prevents delays, and provides visibility into work-in-process and due dates
  • Provides automated delivery of reports to recipients based on case characteristics, product identity, and recipient requirements resulting in timely, accurate, and flexible regulatory compliance
  • Enables users to meet deadlines through its support of general-case lists reports, blinded reports, and periodic reporting requirements for line listings of events and as well as detailed analysis of the impact of new findings on the safety profile of the product in an automated and coordinated manner
  • Provides a fundamental building block for efficiently capturing and managing adverse event report data across the full product life cycle from clinical development through post-marketing
  • Can deliver a powerful and complete platform for companies to realize the benefits of proactive pharmacovigilance and risk management when combined with advanced techniques such as data mining, data visualization, and signal detection and management products
  • Can be used in a 21 CFR 11-compliant environment
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