COMPLIANCE EVIDENCE ENGINE

Clinical-trial evidence.
Visible. Explainable. Traceable.

Understand what the accumulated documentation supports about study conduct, where it conflicts, and what remains uncertain.

THE QUESTION BEHIND THE DOCUMENTS

What does the evidence
say about your study?

Trial documentation records how a study is being—or was—conducted. Understanding it requires connecting facts across documents, people, sites and time. Missing evidence can be as important as a contradiction.

What is supported?

Identify the evidence supporting an assessment and trace it to its source.

What is inconsistent?

Surface conflicts between sources, versions and timelines.

What remains unknown?

Make missing or insufficient evidence visible for human review.

HOW CEE WORKS

Rules first.
AI where interpretation is needed.

CEE combines a defined study-evidence model, deterministic controls and constrained AI reasoning. The result is a reviewable assessment connected to its supporting evidence.

01 / STRUCTURE

Extract the facts

Organise artefacts into profiles and structured facts.

02 / CONNECT

Build the context

Link entities, relationships and events over time.

03 / EVALUATE

Assess the evidence

Apply defined controls and AI-supported interpretation.

04 / ASSERT

Make it reviewable

Present conclusions with provenance for expert assessment.

CEE IN PRACTICE

The finding.
The evidence. Your review.

These screenshots from the CEE presentation show how an assessment is accompanied by supporting documents and made available for expert review.

01 / INVESTIGATIONAL PRODUCT CONTROL

Is monitoring continuity supported?

CEE identifies a gap between temperature-log documents. The observation states that continuity cannot be confirmed from the available evidence; it does not establish that a temperature excursion occurred.

CEE temperature monitoring assessment showing one gap between log documents, supporting evidence and reviewer controls.

Product screenshot · select the image to open it at full resolution.

02 / STUDY GOVERNANCE

Does approval evidence match the protocol?

CEE correlates IRB/IEC approval records with protocol versions and flags a potential mismatch for review. The underlying evidence remains available to check the conclusion.

CEE study-governance assessment showing an ethics-approval assertion and its supporting decision-letter records.

Product screenshot · select the image to open it at full resolution.

ONE EVIDENCE LAYER. TWO DECISION CONTEXTS.

During the study.
When assessing the asset.

ONGOING TRIAL OVERSIGHT

Guide review
and follow-up.

Identify potential consent, qualification, governance, timing and investigational-product documentation issues. Give clinical and quality teams a traceable basis for investigating findings and addressing gaps.

CLINICAL-ASSET DUE DILIGENCE

Understand the evidence
behind the asset.

Assess what historical study documentation establishes, where it raises concerns, and what remains unresolved. Clinical, regulatory and quality experts interpret the implications for the asset assessment.

HUMAN-IN-THE-LOOP BY DESIGN

Evidence informs.
Experts decide.

Findings and assertions support review; they do not replace expert judgement. Coverage depends on the evidence available and the review questions configured for the evaluation.

Explore CEE with Allyfe’s document platform →

START WITH YOUR STUDY

Make your next review
an informed one.

Explore the workflow in a demonstration, or discuss a focused evaluation with agreed review questions and success criteria.

Book a demo ↗