Assure layer · Module 08Evidence Engine
Explainable AI, on every layer of the trial.
Evidence Engine runs across every ECS® layer, Engage, Conduct, Capture, Operate and Assure, and extends into the Armonia community add-on. It drafts, detects and proposes, shows the inputs and the model version behind each output, and hands the pen back to a qualified human for every decision that reaches a regulator.
Purpose-built, module by module.
Auto-drafts eCRF queries from edit-check failures, cross-form inconsistencies and outlier detection, reviewer accepts, edits or rejects with one click.
Continuous scan across visits, dosing, eligibility and windows, surfaces potential deviations with the rule that fired and the evidence trail.
Structured comparison of source to CRF, flags mismatches, prioritises risk, lets monitors focus on judgement.
First-draft SAE narratives from structured MedDRA-coded data, medical writer reviews, edits and signs; provenance retained.
Match community members to eligible protocols with explainable criteria, every match shows the reasoning and the data it used.
Detects unusual patterns in participant-reported outcomes, response fatigue, straight-lining, non-adherence, flagged with confidence.
Signal extraction from continuous device streams, with explainable summaries a clinician can read at a glance.
MedDRA and WHODrug coding suggestions from free-text terms, coder retains authority, model retains the receipts.
Every output ships with the inputs, the model version, the prompt and the confidence, no black boxes, no hidden weights.
Every regulator-facing artefact is signed, submitted and closed by a qualified human, on the record.
Model registry, change control, drift monitoring and incident logging, inside the same GxP-grade audit trail as the rest of ECS®.
Models run where the data lives. Answers travel, records don't, privacy by architecture.
Regulatory & standards frame.
The regulatory and standards backdrop this module is designed against.
Risk classification, data governance, transparency and human oversight designed to Annex III obligations.
Investigator and sponsor oversight preserved, AI proposes, humans decide and sign.
Aligned to FDA/Health Canada/MHRA GMLP guiding principles for medical AI.
Every AI output is logged with model version, prompt, inputs and the human who accepted it, full electronic-record trail.
AI lifecycle governance, model change control, monitoring and incident response.
Trustworthy AI principles, valid, reliable, safe, secure, accountable, explainable, privacy-enhanced, fair.
Built to be handed to a regulator, with regional data residency in the sponsor's jurisdiction.
The rest of ECS®.
Trace every result, from capture to report.
Every action is dated, attributed and documented. We'll show you how the data trail works.