FICS Sentinel · Continuous Data Integrity Monitoring

FICS Sentinel continuously monitors the unified FICS record for integrity issues that traditional edit checks, SDV, and outlier statistics miss, including fabrication patterns that appear “too clean, too fast,” after-the-fact changes, and suspicious access outside normal scope or hours. It surfaces problems early, before they reach a go/no-go decision.

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FICS Sentinel escalation report showing a high-severity finding, with decision, hypothesis, evidence tested against raw records, and a recommended action.

What it is

FICS Sentinel is a continuous monitor for the unified FICS record. Clinical software already blocks obvious data-entry mistakes; FICS Sentinel watches for the ones that pass every rule and still shouldn't have happened, fabrication that reads as "too clean, too fast," after-the-fact changes, and suspicious access at odd hours or out of scope. It surfaces integrity and quality issues that traditional SDV and outlier statistics miss, before they reach a go/no-go decision.

Who it's for

Data managers responsible for clean, audit-ready data; quality and RBQM reviewers advancing beyond sampled source-data verification; and sponsors making go/no-go decisions who need confidence that the data beneath each call is sound by design rather than reconstructed in an end-of-study scramble.

The stakes

Why data integrity decides so much, so early

~70%

Of trials discontinue in Phase II, where the pivotal go/no-go call is made

~90%

Of drug candidates never reach approval, so every advancement decision has to hold up

2–3×

More major compliance issues flagged early by centralized monitoring than by traditional SDV

Up to 30%

Of the trial budget goes to site monitoring, more than half of it SDV alone

13 days

From LPLV to database lock with continuous cleaning, against a 37-day industry average

6×

Cleaning throughput in a 2025 study, with error rates falling from 54.7% to 8.5%

Figures are drawn from cited industry studies and the FICS Sentinel overview. They are directional benchmarks that vary by therapeutic area, phase, and design.

Capabilities

What FICS Sentinel does for a program

Decision Integrity

Protect the go/no-go decision

Continuously checks that the data supporting each decision is internally consistent and faithfully recorded, so a candidate advances or stops on its real merits, not on data that only looked clean.

RBQM Enhancement

The next step beyond centralized monitoring

Advances past standard KRIs, QTLs, and outlier statistics. Because it runs on the single unified FICS record instead of stitched-together systems, it reasons over every source continuously.

Efficiency

Less manual verification, lower monitoring spend

Automated, continuous coverage of the entire FICS record means verification can be aimed where it matters instead of applied everywhere, reducing manual monitoring spend.

Speed

Reach a locked, trustworthy dataset sooner

By keeping data clean throughout execution instead of piling issues up for end-of-study cleanup, the stretch from last patient visit to database lock shrinks.

Built for the moments where data quality decides everything

See how FICS Sentinel watches the unified FICS record continuously, so the data behind every dose, safety read, and go/no-go is sound by design.

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