A trial that speaks for itself — in real time.
OmniScience is engaged in research collaborations poised to deliver the first real-time signals to regulatory reviewers via a regulatory-compliant framework.
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 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
↓
Regulatory reviewers
Early visibility during the trial — every signal traceable to source
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 ↗
Be ready when review goes real-time.
Talk to us about the PRISM consortium and what real-time readiness means for your trials.
