Read the documents
CEE extracts key facts from documents, including dates, versions, people and sites.
CLINICAL TRIAL OVERSIGHT & INSPECTION READINESS
See where your trial documentation doesn’t hold together.
Allyfe’s Compliance Evidence Engine (CEE) 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.
Add evidence review without replacing your existing document-management system.
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.
COMPLIANCE EVIDENCE ENGINEEvidence review
FROM FINDINGS TO SUPPORTING EVIDENCE
A gap in monitoring.
The evidence behind it.
CEE interface · finding shown on a synthetic study
Explore the example at full size →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.
Connect the facts
It links those facts across documents, people, sites and study events.
Find inconsistencies
It applies defined checks across documents: rules for clear-cut comparisons and AI where interpretation is needed.
Review each finding
Each finding comes with its supporting documents. Your reviewer accepts, changes or rejects it.
HOW CEE USES AI
AI that shows its work.
Rules handle defined comparisons across documents. AI helps interpret document content and extract the facts used in those checks.
Each finding includes supporting evidence for your reviewer to inspect, accept, change or reject. Coverage depends on the documents available and the checks configured for your study.
CONNECTIVITY
Connects to what you already use.
CEE adds evidence review to your existing document environment through adapters or document upload. API-based connections to eTMF systems depend on the access provided by your vendor and licence. Other adapters are scoped, built or configured for your environment.
Document sourcesAdapter or uploadCEEFindings for review
Existing eTMF systems
API-based connections can be scoped where your eTMF provides suitable document access and your licence and permissions allow it. Alternatively, start with a document export and upload.
Shared drives & folders
Use the SharePoint adapter route or upload a selected document set from a network drive or structured folder.
Local & in-house systems
Discuss access requirements with your IT team. Any direct adapter development or configuration is defined for the project.
Document upload
Review an authorised export from a data room, an archive or a partner’s eTMF without a direct system integration.
Your existing system remains the source of record. CEE accesses selected documents to extract and connect evidence.
Read about data handling and AI →FLEXIBLE BY DESIGN
Two ways to work with Allyfe.
Review documents from your existing eTMF—or use CEE with Allyfe Records Management.
Keep your systems.
Add CEE.
Add CEE to your existing document environment without replacing your system of record.
See how ↑Run CEE on one of your studies →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.
Explore Records Management →BUILT AROUND YOUR TEAM
One evidence trail. Three teams that rely on it.
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.
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.
Use authorised document exports from data rooms, archives or a partner’s eTMF. Direct connections are assessed during setup.
Explore CEE for due diligence →
WHY WE’RE BUILDING ALLYFE
An inspection shouldn’t be the first time anyone sees how a study’s documents fit together.
I’m building Allyfe because, working alongside clinical sites on our first product, I saw how much time went into finding documents—and how difficult it was to check that they told the same story. Our approach is simple: connect the evidence across a study, show where it conflicts, and leave the judgment to the experts who know the trial. We develop CEE with clinical and quality teams, using design-partner feedback to refine the checks and review workflows.
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.
SEE IT FIRST
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 →