Panorama TMF QC assesses eTMF structure, metadata integrity, completeness, traceability, and ALCOA+ evidence at scale — and returns structured findings your team can review, challenge, and remediate.
Manual TMF QC doesn't scale — and the real constraint is calendar time.
Teams still open records one by one, reconcile metadata by hand, chase version drift, and assemble inspection narratives from fragmented evidence. Larger files mean longer queues, slower remediation, and later visibility into readiness risk.
01
Every record can be touched by the workflow — not just a limited sample.
02
Evidence is organized into structured findings and reviewer-ready outputs.
03
Human review stays in control — but starts from a far sharper evidence base.
Why Panorama
Not a chatbot. Not cheaper manual review. Not a black box.
Structured inspection logic
Rules, thresholds, and dependency checks applied across the file — not open-ended prompt-and-response review.
Built for time compression
The goal is to move the inspection-readiness finish line closer — not simply swap expensive review labor for cheaper labor.
Evidence-bounded outputs
Findings tie back to records, metadata, and review logic — so teams can inspect, challenge, accept, or remediate the result.
Inspection domains
What Panorama TMF QC checks
Readiness is evaluated across the areas that matter when an inspection narrative must be complete, traceable, controlled, and reconstructable. Hover or tap a domain to explore.
Domain 01
Foundation
The structural baseline — how the file is organized and whether its metadata holds up.
✓ Filing model and category inventory
✓ Metadata completeness and quality signals
✓ Record universe and coverage ledger
Domain 02
Trial Design Control
Whether the trial's design is fully represented and traceable through its changes.
✓ Protocol and amendment lineage
✓ Downstream obligations and impact areas
✓ Design-to-document traceability
Domain 03
Approvals & Consent
Whether approvals and consent are present, correctly timed, and aligned to the right versions.
✓ Approval matrices and timing
✓ Consent inventories and version alignment
✓ Cross-checks against design changes
Domain 04
Site Readiness
Whether each site was ready and authorized before it acted.
✓ Startup and activation evidence
✓ PI qualification and delegation
✓ Training coverage
Domain 05
Subject Management
Whether the subject record holds together across consent, eligibility, and flow.
✓ Consent timing per subject
✓ Eligibility coherence
✓ Subject-flow and evidence consistency
Domain 06
Safety Documentation
Whether safety information is controlled and its downstream effects are honored.
✓ IB version control
✓ Safety evidence and reporting
✓ Downstream approval and consent impacts
Domain 07
Monitoring, Deviations & CAPA
Whether oversight happened and issues were carried through to closure.
✓ Oversight coverage
✓ Deviation and issue traceability
✓ Recurrence patterns and CAPA linkage
Domain 09
Closeout & Readiness
Whether the file can stand on its own at the finish line.
✓ Open gaps and unresolved risks
✓ Reconstructability assessment
✓ Inspection-readiness conclusion
Domain 08 · ALCOA++
Data Integrity
The ALCOA++ assessment — every reviewed record weighed against ten data-integrity attributes, evaluated across metadata, the raw file, and the audit trail together.
✓ Metadata, raw file, and audit trail assessed together
✓ Every conclusion tied to cited evidence — or flagged where a record can't be trusted
How it works
From raw export to reviewer-ready evidence.
STEP 01
Extract
Start from a defined TMF export. No live-system access required.
STEP 02
Inspect
The workflow touches every record, applying rules, thresholds, and dependency checks.
STEP 03
Evidence
Findings are tied back to records, metadata, and the logic that produced them.
STEP 04
Review
Your team inspects, challenges, accepts, or remediates — human review stays in control.
Security & confidentiality
Built to protect participant data and the trial blind.
Panorama works from a defined export, inside an isolated environment. Your data is never sent to the cloud and never shared with third parties.
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Isolated environment
All work runs in an isolated environment. We never send your data to the cloud and never share it with third parties.
02
No live-system access
Assessment runs on a defined TMF export. Panorama never needs credentials to your live eTMF.
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Participant data protected
Personal identifiers are never transcribed into findings; participant-level evidence is referenced by location, not reproduced.
04
The trial blind respected
Blinding-sensitive content is treated as restricted and cited by location only — never exposed in outputs.
05
Auditable by design
Every conclusion is tied to the record, metadata, or audit event behind it, and stays human-reviewable.
Outputs
Reviewer-ready evidence, not vague AI commentary.
Structured outputs that clinical operations, quality, compliance, and inspection-readiness teams can actually use.
✓TMF record universe and coverage ledger
✓Baseline metadata and filing-quality checks
✓Rules-driven inspection findings
✓Dependency and decision logic
✓Reconstructability assessment
✓ALCOA+ supporting evidence review
✓Reviewer-ready package for remediation planning
100%
Record-level coverage target
Every record
Reviewed, not just sampled
1
Reviewer-ready evidence package
The firm behind Panorama
Built by regulated-industry technology leadership.
WCSSRG brings enterprise technology, compliance, inspection-readiness, and systems-governance experience into a focused TMF QC product. Advisory services remain available — Panorama TMF QC is the primary offer.
Regulated systems experience
Practical depth across enterprise platforms, governance, compliance, data, and quality operations.
Inspection-readiness focus
Designed around the evidence and reconstructability questions that matter for defensible answers.
AI with evidence discipline
AI runs inside bounded workflows, with outputs that stay traceable, reviewable, and challengeable.
See what a virtual inspector finds in your TMF.
Start with a defined TMF extract. Panorama assesses structure, metadata, traceability, and reconstructability — then returns structured findings your team can review.
01 · SCOPE
We agree on a defined TMF extract and the questions that matter.
02 · ASSESS
Panorama works through the records and assembles cited findings.
03 · REVIEW
You get a reviewer-ready package to challenge, accept, or remediate.