A private study repository
Manage study, centre and essential-document records. File downloads are authorised; files are not served through permanent public URLs.
All modules →DraftApprovedIn ReviewApproved
Pharma Intelligence / Clinical operations
Clinical Trials eTMF
Every document. Every version. An accountable decision.
Clinical Trials eTMF
Illustrative demo · Fictional data
DEMO-A01 / Phase II
Aster document operations
6Expected
2Approved
1In review
1Missing
Document completeness
Approved2
In Review1
Draft1
Rejected1
Missing1
File-backed Approved / expected in selected scope
Independent review
Site initiation checklist
West Centre · v1 · File retained
DraftIn ReviewApproved
Owner submits. Assigned reviewer decides.
Fictional study selected. Expected-document matrix loaded.
Document register
4 pending requirementsSite initiation checklist
West Centre · v1
Study protocol
Study-wide · v2
Investigator brochure
Study-wide · v1
Site initiation checklist
North Centre · v1
AI metadata assistance
Suggested category: Site management
Awaiting consent
Metadata only. No approval implied.
Activity / audit trail
- Fictional study selected. Expected-document matrix loaded.
From scattered files to reviewable context
Know what is present. See what needs attention.
Bring study documents, retained versions and explicitly assigned review into one clear operational view. Keep private clinical files private.
Implemented capabilities
Structure across the document lifecycle.
Versions that remain available
Retain earlier file versions with author, date and update reason. Registered file integrity is checked before download or AI analysis.
Readiness by study and centre
Compare expected documents against existing records. Distinguish missing, Draft, In Review, Rejected and Approved using a configurable basic matrix.
Independent review, explicitly assigned
Invite existing accounts, require acceptance and assign study access. Owners edit; authorised reviewers decide. Self-approval is blocked.
AI assistance with human control
An owner explicitly consents to analysis of an eligible private Draft file. Source-labelled, version-bound suggestions need human confirmation before metadata changes.
Reports grounded in document status
Export CSV reports of completeness, document status and protected history. Demo records remain distinct from production records.
A deliberate boundary
Human review is not optional.
Document completeness is an operational measure, not a clinical or regulatory approval. AI suggestions do not approve documents or establish their accuracy.
- 01
Define the expected record
Configure a basic study/centre matrix; the complete official TMF taxonomy is not claimed.
- 02
Retain the evidence
Upload a supported private file, record its metadata and preserve each version.
- 03
Assign the decision
An accepted, assigned reviewer reviews a file-backed version independently.
Readiness, stated precisely
Demonstrated workflows. Separate production gates.
Study registers, private versions, completeness, AI with human confirmation and independent review have been exercised with fictional data. Formal validation for regulated production use is not established. There is no claim of ICH E6(R3) certification, 21 CFR Part 11 certification or FDA approval.
Current file boundaries
PDF, PNG and JPEG up to 10 MiB. AI analysis is limited to eligible files up to 2 MiB.
Outstanding operational gates
Malware screening, personal-data governance, audited orphan reconciliation and independent backup/restore verification remain open.
Access and scale boundaries
Invitations use existing accounts; email invitations are not enabled. Broad enterprise-scale performance has not been established.
From complexity to context
Start with your workflow.
Discuss your document, quality and clinical operations priorities.