Clinical Monitor
Risk-Based Monitoring
Interactive demo
Protocol-driven · ICH E6(R3) Live EDC API

Monitoring that matches the protocol.

Critical data, key risk indicators and quality tolerance limits derived from each study's own endpoints, not a generic template. Linked to the EDC API, it pulls live SDV coverage and operational metrics as the data lands. Explore it below on a live Phase 1 cardiac gene-therapy trial.

Explore the console
New · Live EDC API integration

Source-data verification, live from the EDC.

SDV coverage is the metric clinical monitors live by. Clinical Monitor connects to the EDC API and grades every field against its protocol-derived plan (100% on critical data, targeted on the rest), so under-verified sites surface the moment the data lands.

64.4%
Overall SDV
100%
Critical verified
22
Fields tracked
Linked to the Fountayn EDC API (mock) · connected · live feed · queries & data-review coming soon
clinical-monitor.app / studies /
Method

From protocol endpoints to targeted oversight

1

Protocol endpoints

Endpoints & critical processes captured as structured data.

2

Derive artifacts

Critical data, KRIs (site-level) & QTLs (trial-level).

3

Monitor centrally

Statistical & fixed-threshold signal detection.

4

Act

Targeted, risk-based on-site follow-up.

Aligned with the RBQM lifecycle: ICH E6(R3) · FDA (2013 + 2023 Q&A) · EMA · TransCelerate RACT. KRIs assess site performance; QTLs flag systemic, trial-level issues. Every derived artifact traces to the endpoint it came from.