A trial that speaks for itself — in real time.

The channel that carries the trial's signals to reviewers during the trial, not only at its end — the same signals your teams already see, delivered in the reviewer's own format, each traceable back upstream to source.

Talk to Us Real-Time Trial Readiness

The Vision

Regulatory review shouldn't wait for the trial to end.

OmniScience collaborates with the U.S. FDA on Real-Time Clinical Trials policy, and is part of the PRISM consortium — multiple large pharma teams and supporting vendor organizations — poised to deliver the first real-time signals to regulatory reviewers in SDTM format via a regulatory-compliant framework.

Early signals delivered to reviewers throughout the trial
SDTM format — the reviewer's own language, not a new one
Every signal traceable back upstream to the source record
Built on the same governed foundation that runs the trial

The Channel

The running trial

Signals, risks, and alerts on the governed foundation — what your teams already see

↓ continuous, not end-of-trial

Regulator-ready packaging

SDTM-formatted, compliant framework, human-reviewed release gates

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Regulatory reviewers

Early visibility during the trial — every signal traceable to source

Getting Ready

Real-time readiness starts with the foundation you run on today.

Teams preparing for continuous oversight models need unified data, monitored signals, human review gates, and evidence packages — which is exactly what running your trial on Vivo builds, trial by trial.

Unified, governed data

One validated foundation across sources — the prerequisite for any real-time claim.

Continuously monitored signals

AI-RBQM watching every source, with thresholds your team governs.

Human review gates

Nothing leaves the sponsor's walls without governed, documented review.

Evidence packages

Source-to-signal traceability preserved for audit, inspection, and review.

Reading on the shift: Real-Time Trials Are Coming: Is Pharma Ready? ↗ · Eliminate the Wait ↗