NWEH upgrades trial safety reporting with real-time EHR and E2B

NorthWest EHealth has enhanced its ConneXon platform to detect and report potential adverse events from electronic health records in near real time. The update aims to speed up serious adverse event reporting, reduce manual errors and give sponsors earlier visibility into safety signals.

Why it matters: - Clinical trial safety reporting often lags behind events by days or weeks. - NWEH’s update is designed to shorten that gap, which can help sponsors spot safety signals earlier and make faster decisions. - The system is also intended to reduce manual work for sites and improve submission readiness for sponsors.

What happened: - NorthWest EHealth, or NWEH, enhanced the clinical trial safety surveillance function in its ConneXon platform. - The upgraded system links directly to electronic health records and flags potential adverse events in near real time. - NWEH says the updated capability can generate Individual Case Safety Reports, or ICSRs, faster and more accurately.

The details: - NWEH says ConneXon’s EHR-based safety surveillance has detected up to twice as many serious adverse events as traditional methods. - NWEH estimates the updated ICSR capability saves an average of five hours per report. - The platform combines real-time EHR data with expert clinical oversight from NWEH’s in-house safety team. - Clinical experts review potential events against the trial protocol’s adverse event criteria before reporting. - When reporting is required, the system uses ICH E2B(R3) to standardize generation and transmission to sponsors. - NWEH says the workflow reduces transcription errors and lowers the burden of manual reconciliation between sites and sponsors. - The company says the approach aligns with FDA guidance on risk-based monitoring, which supports continuous monitoring for patient safety, accuracy and trial efficiency. More information - The release says serious adverse events should be reported promptly under ICH Good Clinical Practice, and European and UK guidance sets a 24-hour timeline. - The release says missed reporting deadlines can count as a Good Clinical Practice breach and may damage reputation or delay studies. - NWEH says the system reduces reliance on participants remembering to report events at scheduled visits.

Between the lines: - The update reflects a broader push in clinical research toward continuous monitoring instead of visit-based reporting. - NWEH is positioning clinical judgment as a safeguard alongside automation, not a replacement for it. - The company is also arguing that better data flow can improve both participant protection and operational efficiency.

What’s next: - NWEH says the upgraded workflow should help sponsors assess potential adverse events sooner and make more timely decisions. - The company expects the system to support ongoing safety assessment and earlier signal detection. - NWEH also says the platform should help sites focus more on patient care and less on administrative reporting tasks.

The bottom line: - NWEH is turning EHR data into a faster safety-reporting pipeline, with the goal of getting credible trial safety information to sponsors in hours instead of much longer manual cycles.