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CLINICAL TRIAL OVERSIGHT & INSPECTION READINESS

See where your trial documentation doesn’t hold together.

Allyfe’s Compliance Evidence Engine checks clinical-trial documents against each other and shows the evidence behind every finding, so your team can investigate gaps before an inspection or audit.

Alongside your existing systems. Or integrated with Allyfe.

COMPLIANCE EVIDENCE ENGINEEvidence review

FROM FINDINGS TO SUPPORTING EVIDENCE

A gap in monitoring.
The evidence behind it.

CEE screenshot showing a gap between temperature-monitoring logs, supporting documents, and Accept, Change and Reject review controls.

CEE interface · example from the product presentation

Explore the example at full size →

THE PROBLEM BETWEEN THE DOCUMENTS

Each document can look complete.
The study evidence can still conflict.

Reviewing a document on its own cannot show every conflict with evidence elsewhere. An approval record may not match the protocol version. Separate temperature logs may leave a gap in monitoring. These issues emerge when you compare documents across the study.

CEE brings those relationships into view, with the supporting evidence your team needs to investigate.

For the teams responsible for trial evidenceSponsors & biotechCROsSites & academic hospitals

HOW CEE WORKS

From documents to a reviewable finding.

Focus QC attention on documents that disagree and evidence that is missing. CEE connects the facts and shows the source documents; your team decides what needs action.

01 / READ

Read the documents

CEE extracts key facts from documents, including dates, versions, people and sites.

02 / CONNECT

Connect the facts

It links those facts across documents, people, sites and study events.

03 / CHECK

Check for inconsistencies

It applies defined checks across documents: rules for clear-cut comparisons and AI where interpretation is needed.

04 / REVIEW

Review each finding

Each finding comes with its supporting documents. Your reviewer accepts, changes or rejects it.

EXPERTISE STAYS AT THE CENTRE

See the issue.
Follow the evidence.
Decide what to do.

CEE helps your team understand why a potential issue has been raised and which evidence supports it. Assessments cover defined review questions. Your experts determine the significance and the appropriate action.

Book a demo →

FLEXIBLE BY DESIGN

Two ways to work with Allyfe.

01 / ADD EVIDENCE REVIEW

Keep your systems.
Add CEE.

Assess selected study evidence through supported connections or document upload, alongside your existing document environment.

Existing repositoriesDocument uploadEvidence review
Run CEE on one of your studies →
02 / CONNECT THE WORKFLOW

Need an eTMF? Start with Records Management.

For sites, academic hospitals and smaller sponsors moving beyond spreadsheets, Allyfe Records Management brings site start-up, eISF, eTMF and remote QC together, with CEE in the same workflow.

Site start-upeISF & eTMFRemote QC
Explore Records Management →

BUILT AROUND YOUR TEAM

Shared evidence.
Better-informed decisions.

Sponsors & biotech

Use CEE’s linked evidence to investigate cross-document inconsistencies and organise follow-up before an audit or inspection.

CROs

Give your QC reviewers the source documents behind each finding, so they can assess it and discuss follow-up with sponsors and sites.

Sites & academic hospitals

Connect site records with study evidence, review documentation gaps and coordinate responses within your research team.

Allyfe combines CEE evidence review with optional Records Management. Based in Belgium, we help sponsors, CROs and research sites investigate the evidence behind their studies.

CLINICAL-ASSET DUE DILIGENCE

Before you license or acquire an asset,
understand what its trial records support.

Use CEE to examine selected historical study documentation, trace inconsistencies to their sources and identify questions for further review. Your clinical, regulatory and quality experts assess the implications for the asset.

Explore CEE for due diligence →

DESIGN-PARTNER EVALUATION

Run CEE on one of your studies.

Start with a focused evaluation of selected study documentation. Together, we agree the review questions, available checks and success criteria before work begins.

What your team gets

A scoped review of the selected evidence, findings linked to their source documents, and a joint discussion of what the results mean for your workflow.

What we need from you

An agreed document set, appropriate permission to use it, an expert reviewer and feedback on the findings. Data handling, access and evaluation terms are agreed before documents are shared.

START WITH YOUR STUDY

Start with a walkthrough.

Book a demo for a short walkthrough of CEE, its supporting evidence and the reviewer’s Accept, Change and Reject workflow.

Book a demo ↗