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Home : Products : Safety Solutions : Adverse Event Reporting

Adverse Event Reporting

Empirica™ Trace

The ability to manage the risk of safety problems begins with accurate, timely and complete data about adverse events. Phase Forward’s Empirica Trace product helps many types of organizations – small, medium and large biopharmas, medical device manufacturers and CROs - collect, code, analyze and report adverse events, as well as meet regulatory reporting deadlines and global requirements. This Web-based product provides a single, powerful and modern solution for adverse event management which helps to speed information delivery, prevent delays, and provide visibility into work-in-process and due dates.

Timely, Accurate and Flexible Regulatory Compliance. New report distribution functionality, based on flexible pre-defined rules, provides automated delivery of reports to recipients based on case characteristics, product identity and recipient requirements much more efficiently than manual reporting.

The Empirica Trace product supports general case lists reports, blinded reports and periodic reporting requirements for line listings of events and detailed analysis of the impact of new findings on the safety profile of the product in an automated and coordinated manner. This enables deadlines to be promptly met with complete and accurate information.

Empirica™ Gateway. Phase Forward’s Empirica Gateway product streamlines the exchange of electronic case safety information with regulatory agencies, affiliate offices and trading partners. The Gateway product is designed to adhere to specifications established by ICH, EMEA, MHLW and FDA, including the FDA's latest Electronic Submission Gateway (ESG) standards. The Gateway product also offers expanded submissions tracking and acknowledgements via integration with the Empirica Trace product, and enhanced application security.

Proactive Pharmacovigilance - a Life Cycle Approach. While data capture and regulatory compliance are fundamental requirements, companies are also increasingly focused on identifying ways to extract the maximum value from their safety data with highly proactive strategic pharmacovigilance programs. Empirica Trace 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.

Combined with the advanced techniques such as data mining, data visualization and signal detection and management products, the Empirica Trace software can deliver a powerful and complete platform for companies to realize the benefits of proactive pharmacovigilance and risk management.

Powerful Reporting Toolset. The 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 Empirica suite tools may be licensed to support signal detection and analysis, signal management and clinical trials signal detection.

The Empirica Trace system can be used in a 21 CFR 11-compliant environment. Phase Forward's research and development program actively pursues enhancements to the safety solution suite.