Pre.sentient
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Real-Time Trial Analysis Platform

Every trial hasits moment

Pre.sentient continuously analyzes unblinded trial data while keeping every human blinded, identifying the earliest moment to act.

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Statistics is evolving

Continuous analysis formally outperforms a single look, so each patient's data is analyzed as promptly as possible.

Decisions months earlier

The first AI system for rolling interim analysis, blinded to all humans

Pre.sentient helps DMCs convene at the optimal moment, with the evidence they need to act. An interactive dashboard replaces static 500-page reports. Explainable and deterministic AI supports analysis where appropriate.

A rail of interim looks reaching a decision node early

Respond to Safety

Prompt earlier clinical review when unblinded data indicates a potential safety concern, enabling action to protect patients.

A variance field forking into two futures

Adapt the Trial

Support planned adaptations with deterministic AI where appropriate, including sample size re-estimation and changes to inclusion criteria.

A rising trajectory inside a narrowing confidence band

Prepare for Success

Begin regulatory and commercial planning earlier as positive evidence emerges.

Trajectories falling to an early futility detection

Stop for Futility

Identify futility earlier, reducing unnecessary patient exposure and continued investment in studies unlikely to succeed.

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Secure computational enclave

The trial stays blinded.The analysis does not.

Conventional interim analyses require exposing unblinded data to humans before meaningful decisions can be made.

Pre.sentient’s infrastructure continuously evaluates unblinded comparative data inside a secure computational enclave where no human has access, reducing a source of operational bias. When prespecified statistical criteria are met, a signal is released so the DMC can convene at the right moment to review the evidence.

The result is earlier, evidence-based decisions without compromising trial integrity.

Explore the methodology
EXISTING TRIAL DATAAccumulating throughout the trial.SECURE COMPUTATIONAL ENCLAVENo human access, not the sponsor, not us.Continuous analysisVALIDATED DECISION SIGNALReleased for independent review.THRESHOLDTHE MOMENTEarliest defensible moment to act.
CertifiedISO/IEC 27001ISO 9001
Supported21 CFR Part 11EU GMP Annex 11
Security & Compliance
Evidence

The evidence behind Pre.sentient

Explore the methodology, simulations, regulatory engagement, and validation evidence behind the approach.

PublicationsPeer-reviewed papers and regulatory materials behind the method.Statistical methodologyRolling analysis, alpha preservation, and the simulation framework behind every look.Regulatory engagementA positive EMA meeting, an FDA ISTAND submission, and written FDA comments on trial-level use.Trust CenterSecurity posture, validation evidence, certifications, and compliance documentation.

Frequently asked questions

Pre.sentient evaluates unblinded trial data inside a secure computational enclave that runs the trial's statistical analyses. The unblinded data is never exposed to investigators, sponsors, or other humans. Only validated decision signals are released when predefined statistical criteria are met. Our approach carries a lower risk operational bias compared to the status quo.

How It Works

Every signal is backed by validated statistical methodology and a complete, auditable record, providing the transparency needed for independent review and regulatory confidence.

Statistical Methodology

Pre.sentient connects to the systems you already use, continuously ingesting only the data required for analysis, minimising operational workflow changes.

Our Platform

Security, validation, auditability, and compliance are foundational to ensure confidence in the underlying statistical analysis. Pre.sentient is engineered around that need: an ISO/IEC 27001 certified security management system, ISO 9001 quality processes, and controls designed to support your obligations under 21 CFR Part 11 and EU GMP Annex 11. The certificates and documentation behind those claims are available in our Trust Center. ~40% of Pre.sentient employees come from a cybersecurity background, which reflects how we prioritize the security of our enclave architecture.

Trust Center

No alpha is spent. For monitoring for futility, this cannot initiate stopping for success so there is no Type I error inflation. False negative error is controlled by simulation across the whole monitoring sequence. Our approach for monitoring for likely success is used as a business intelligence signal and is not designed to initiate early stopping of the trial for success, and as such has no Type I error inflation. The rolling analysis is not a sequence of hypothesis tests against the primary endpoint, so the trial's type I error rate and its pre-specified design are untouched.

Statistical Methodology

Find the moments that matter in your trial

Talk with Pre.sentient about where continuous analysis could create earlier, better-informed decisions across your clinical development portfolio.

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