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

Suggested Articles

There's no evidence personal patient information leaked during the 11-week breach, but the same can't be said about Sangamo's own secrets.

Through a new online tracker, AllTrials names sponsors who fail to report clinical trial results on time per the FDAAA Final Rule.

The new solution aims to streamline the incorporation of human genomic data into clinical trial designs.