AccuraTrials ingests your protocol and builds a governed model of the study — every eCRF, validation rule, and task carrying the exact clause it came from. Nothing is accepted until a human approves it, and every decision traces back to source evidence.AccuraTrials ingests your protocol and builds a governed study model — every eCRF, rule, and task cites the clause it came from, human-approved, fully auditable.
Every phase — setup, monitoring, amendments — runs on manual work with no shared intelligence layer. And every slip has a price.Every phase runs on manual work with no shared intelligence layer. Every slip has a price.
eCRFs, specs, and validation rules hand-built per study, every time. No carry-forward. No intelligence.
No protocol-aware monitoring — deviations surface only when someone manually checks, and mandated follow-ups aren't auto-triggered.
One protocol change cascades through forms, rules, sites, training, and documentation — all reconfigured by hand, every time.
"One trial can touch 20–50 systems. The greatest risk is not inside each system — it is in the handoffs between them."
An intelligence layer that ingests every source document and human decision, builds a governed model of the study, and monitors the trial across every clinical system.An intelligence layer that ingests source documents and decisions, builds a governed study model, and monitors the trial across every system.
AccuraTrials ingests the protocol and generates a governed study model. Every eCRF, rule, and task carries its source clause — and requires human sign-off before it's accepted.The protocol goes in; a governed study model comes out. Every output carries its source clause and needs human sign-off before it's accepted.
Every output maps to the exact protocol clause, section number, and page it was drawn from.
The rule and logic that produced the output are captured and shown — never a black box.
The reviewer, timestamp, and every edit are recorded before anything is accepted.
Immutable, versioned, and reconstructable on demand for a monitor or an inspector.
Independent study: 5 frontier LLMs, 36 clinician-validated scenarios for source-evidence traceability.
While building toward the full governance platform, we deployed the AccuraTrials EDC into a real Phase I trial and started charging. The intelligence layer is integrating on the same system — the architecture is proven in a regulated environment.We deployed the AccuraTrials EDC into a real Phase I trial and started charging. The intelligence layer runs on the same proven, regulated architecture.
Under the hood: a 200+ page protocol ingested, analyzed, and recalled through the extraction layer — every output mapped to its source document, then reviewed by a human before it goes anywhere near a patient record.
Regulatory bodies are standardising on the protocol as the governing source of truth — not eCRFs or validation rules alone. Legacy tools were built the other way around. AccuraTrials was designed for what's coming.Regulators are standardising on the protocol as the source of truth. Legacy tools were built the other way around; AccuraTrials was designed for what's coming.
Digital Data Flow makes the structured protocol the governing source for every clinical system — eCRFs, edit checks, and task flows generated from it, not hand-built and disconnected.
Updated Good Clinical Practice explicitly requires structured, risk-based, auditable data management with full traceability to source and human-in-the-loop oversight.
AI in clinical development is acceptable only if every output traces to source evidence with documented human sign-off. AccuraTrials is built through that gate — not retrofitted to it.
"What stands out is not just the AI — it is the control around it. Every output remains visible, reviewable, and auditable."
Clinical trials spend $500K–$3M+ on manual data management per Phase II/III study. AccuraTrials replaces that spend with software — starting at study setup and expanding across the trial.Trials spend $500K–$3M+ on manual data management per study. AccuraTrials replaces that with software, starting at setup.
Intelligence layer + EDC pilot. A 6-week engagement: protocol to sourced eCRFs, rules, and audit trail. Live today.
Deviation monitoring and source-linked AI actions across the study — priced against the manual work it replaces.
TMF, CTMS, ePRO, and safety integration. The same governed brain, a broader footprint across the full trial.
Protocol in, governed outputs out — every decision traceable to source evidence and signed off by a human. Live in a real trial today.