Panorama provides a rule‑based virtual inspector for electronic Trial Master Files (eTMF) that automatically evaluates file structure, metadata quality, completeness signals, and ALCOA+ evidence across the entire TMF.
Funding
Funding not disclosed
Founders
Product
Problem
Clinical trial sponsors and CROs must manually review large volumes of eTMF documents and metadata to demonstrate inspection readiness, a process that is time‑consuming, error‑prone, and difficult to scale.
Solution
Panorama TMF QC provides a structured virtual inspector that applies rule‑based workflow logic to evaluate eTMF structure, metadata integrity, completeness signals, and ALCOA+ evidence. The platform automatically checks dependencies, thresholds, and branch logic across the entire TMF, generating findings that are directly tied to source records. Human reviewers receive reviewer‑ready evidence packages—including coverage ledgers, inspection findings, and reconstructability assessments—allowing them to focus on remediation rather than manual data gathering. By compressing the time between a “ready‑or‑not” query and a defensible, evidence‑backed answer, Panorama accelerates inspection‑readiness while preserving accountable human judgment.
Target Audience
Panorama is aimed at clinical operations, quality, and compliance teams within pharmaceutical sponsors, contract research organizations, and other regulated entities that need to assess eTMF quality and inspection readiness.
Features
- Rule‑based workflow engine that enforces structured inspection logic, thresholds, and dependency checks across the full TMF record set
- Automated evaluation of eTMF structure, filing model, category inventory, and metadata quality (document type, site, milestone, dates, etc.)
- Completeness signal detection for missing, duplicate, misfiled, or unexpected records
- ALCOA+ evidence review to verify attribution, legibility, contemporaneity, originality, accuracy, completeness, consistency, endurance, and availability
- Traceable findings linked to source records, metadata, and the specific inspection rule that generated them
- Branch decision reporting that captures dependency logic and supports reviewer challenge or acceptance
- Consolidated reviewer‑ready output package including coverage ledger, inspection findings, reconstructability assessment, and remediation planning documents