Solutions streamline, rate AE reports

Pegasystems has unveiled an adverse event case processing solution for collecting, managing and analyzing adverse events during and after clinical trials. Meanwhile, Quantros has introduced a rate-based reporting tool.

The Pegasystems solution lets users leverage existing adverse event processing rules, the company says.  It helps streamline the parallel routing and reporting of adverse events to internal and external recipients, for compliance with multiple regulatory jurisdictions. The system also manages and tracks audit trail logs as well as system and user actions, and it can be integrated into a unified dashboard that includes EDC, clinical trial management and pharmacovigilance systems.

Separately, Quantros has introduced the Indicator Scorecard, part of its Safety and Risk Management solution suite. The scorecard provides AE reporting through rate-based metrics. It can also generate facility- and corporate-level data when paired with the company's Safety Event Manager and Denominator Manager.

- here's the Pegasystems release
- see the Quantros release

Sponsored By Metabolon

Five Translational Insights Key to a Successful First-in-Human (FIH) Study – Metabolite-Based Biomarker Discovery and Validation

Translational success rates from pre-clinical animal studies to human clinical trials remain frustratingly low. Learn how metabolomics helps you bridge between the theoretical & practical, between the function & actual activity of your drug molecule to get you closer to the phenotype, sooner.