Electronic Trial Master File
Inspection-ready. Always.
Your Trial Master File organized by TMF Reference Model, complete with real-time metrics, gap analysis, and audit trails. When the inspector arrives, you're ready.
Day 847 of your pivotal trial
The FDA inspector opens her laptop. "Show me the informed consent for Subject 2847."
Your clinical operations lead searches. The consent should be in Zone 3, Section 3.1.3. It's not there. She tries the subject number—nothing. She tries a date range—hundreds of results, none matching.
Fifteen minutes pass. The inspector makes a note.
The consent exists. It was scanned at the site, emailed to the CRO, uploaded to their SharePoint, then exported to your TMF during the quarterly sync. But during the transfer, the metadata got stripped. It's filed as "scan_20240315_001.pdf" somewhere in the system.
The inspection continues. More documents take too long to find. By the end of day one, the inspector has enough observations for a Warning Letter.
Your pivotal trial—847 days in—is now at risk.
The 483s that write themselves
FDA 483 observations for TMF issues follow a pattern:
- "Informed consent forms for multiple subjects could not be located."
- "Monitoring visit reports missing for visits conducted between [dates]."
- "Investigational product accountability records incomplete."
These aren't obscure requirements. The TMF exists to prove the trial was conducted properly. When documents are missing or unfindable, inspectors can't verify conduct. When they can't verify conduct, they question the data.
The question isn't whether you have the documents. It's whether you can produce them in seconds.
Three zones. One truth.
The DIA TMF Reference Model is the universal language of trial documentation:
- Zone 1: Central trial documents. Protocol, IB, regulatory submissions.
- Zone 2: Global oversight. DMC charters, SAE reconciliation, coding dictionaries.
- Zone 3: Site-level documents. Consents, delegation logs, monitoring reports.
Every inspector knows this structure. 01.01.01 is the final protocol. 03.01.03 is the signed consent. 05.01.01 is the monitoring visit report.
In Seal, the TMF Reference Model is built in. Documents classify automatically by zone, section, and artifact. Metadata captures study, site, country, subject. The structure enforces itself.
Know what's missing before they ask
"What's your TMF completeness percentage?"
Inspectors ask because the answer reveals everything. A company tracking completeness knows what's there and what's missing. A company not tracking has no idea what the inspector might find.
Seal calculates completeness in real time:
- Expected artifacts based on milestones. First subject enrolled? You need screening logs, consents, eligibility checklists.
- Present artifacts matched against expectations.
- Missing artifacts with aging. Not just "missing" but "missing for 47 days."
- Overdue QC on documents filed but not reviewed.
The monitoring report from Site 107's March visit has been missing for 23 days. Someone follows up. It arrives. Problem solved—before the inspector ever asks.
Every document's complete journey
The inspector asks: "When was this consent received?"
In Seal, every document has a provenance chain:
- Origin — Site upload, CRO transfer, email, EDC export
- Receipt — System timestamp, not file metadata
- Classification — Auto-classified or manually filed
- QC Review — Who checked it, when, what they found
- Changes — Reclassifications, annotations, redactions
When inspectors ask about provenance, you show them the audit trail. Not memory. Not guesses. The immutable record.
Sites and sponsors, one system
Investigator Site Files mirror the sponsor TMF with site-specific documentation. Protocol copies, delegation logs, screening logs, regulatory correspondence.
Seal manages both. Sites upload through a simple portal—select document type, confirm subject, upload. Three clicks. They see what's missing for their patients. They confirm receipt.
The sponsor sees site-level completeness alongside their own. No surprises about what's at the site versus what's in the central TMF.
Archive today, find it in 2045
The TMF must remain accessible for 15 to 25 years. Your current platform may not exist. Your organization may not exist in its current form. But the documents must remain findable.
Seal's archival:
- Format preservation — Original files plus rendered PDFs
- Full searchability — Archived studies are searchable, not just retrievable
- Same structure — An archived TMF looks exactly like an active one
When FDA has questions about your approved drug in 2045, you need answers in minutes.
Capabilities