Stop rebuilding your TMF before every inspection. Keep it audit-ready every day.
When your eTMF is scattered across shared drives, inboxes and someone's laptop, every inspection turns into a two-week fire drill — and the cost lands on your most senior people. It doesn't have to.
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When your eTMF is scattered across shared drives, inboxes and someone's laptop, every inspection turns into a two-week fire drill — and the cost lands on your most senior people. It doesn't have to.
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You already know how the next inspection starts: with a scramble.
It isn't that your team doesn't care. It's that keeping a TMF inspection-ready by hand — across studies, sites and shared drives — is a job no one can actually win.
Documents live everywhere
Shared drives, inboxes, personal folders. No one can say with certainty what's filed, what's missing, or which copy is the real one.
Completeness is a guess
You find the gaps by hunting for them — usually days before the inspector arrives, when there's no time left to close them calmly.
Version roulette
Three copies of the same document, none clearly current. Reconciling them by hand burns days you can't get back.
No trail you can defend
When an inspector asks who changed what, and when, you're rebuilding the story from email threads instead of pointing to one clean record.
Nights, weekends, your best people
Every inspection becomes late-night filing — and it's always your most senior, most expensive coordinators doing it.
Findings you saw coming
The observations in the report are rarely a surprise. They're the gaps you knew about but never had time to fix.
An inspection becomes just another Tuesday.
You open the TMF the morning the inspector arrives and see one number: 100% complete. No scramble. No surprises. No weekend.
Two-week scramble before every audit
Audit-ready every day, by default
"I think the TMF is complete"
A live completeness score you can actually trust
Hunting for the current version
One source of truth, always current
Rebuilding history from old emails
An immutable audit trail, one click away
Findings you quietly expected
Gaps surfaced and closed long before the inspector finds them
From shared-drive chaos to audit-ready in four steps.
No rip-and-replace year. Here's the path from where you are today to a TMF that's ready before anyone asks.
- 01
Migrate cleanly
We bring your existing TMF in from shared drives, Excel and SharePoint — validated, indexed and mapped to a reference model from day one.
- 02
See every gap
A live completeness dashboard shows what's filed, what's missing and who owns it — in real time, not the week of the inspection.
- 03
Stay current automatically
New documents are captured, classified and filed in the right place by the AI core, so the TMF keeps itself ready without manual effort.
- 04
Hand the inspector a link
Role-scoped access, an immutable audit trail and instant export turn inspection day into a non-event.
Everything that keeps your TMF ready — without the manual grind.
A unified eTMF and eISF on one governed data layer, with the AI and audit controls that make "always ready" realistic instead of aspirational.
Real-time TMF completeness
Always know where you stand. A live dashboard tracks completeness against a reference model and flags missing or expiring documents before they become findings.
- Reference-model-driven completeness scoring
- Missing & expiring document alerts
- Per-study and per-site views
AI filing & classification
Stop filing by hand. The AI core classifies incoming documents, suggests the right placement and validates metadata so the TMF stays current automatically.
- Automatic document classification
- Metadata extraction & validation
- Up to 60% less manual documentation time
Immutable audit trail
Answer "who changed what, when" instantly. Every action is logged append-only with user, timestamp and before/after context.
- Append-only logs across action types
- 21 CFR Part 11 patterns
- One-click inspector export
Governed access & residency
Give inspectors and monitors exactly the access they need — nothing more — with your data kept in the region you choose.
- Role- and site-scoped access control
- Canadian data residency (ca-central-1)
- Separation of duties for sensitive actions
Less scramble. Fewer findings. Calmer inspections.
When the TMF maintains itself, inspections stop being emergencies — and your senior people get their evenings back.
“We used to lose two weeks to every inspection. Now the TMF is ready before anyone asks — the inspection itself is almost boring. That's exactly what you want.”
Answered.
Yes. Validated migration from shared drives, Excel, CSV and SharePoint is part of onboarding. We bring your existing documents in, index them and map them to a reference model so you start with a clear completeness picture instead of a blank system.
It's built for one. MAESTRO Clinical Trials follows 21 CFR Part 11 patterns, maintains immutable audit trails, supports role- and site-scoped access, and is designed to support Health Canada, FDA and sponsor GCP inspections under ICH E6(R3). Validation packages aligned to GAMP 5 are available.
It depends on the volume and state of your current TMF, but the goal of onboarding is exactly this: a complete, indexed, audit-ready TMF with a live completeness dashboard. We'll scope a realistic timeline on the call.
You choose the region. MAESTRO is cloud-agnostic and supports Canadian data residency (ca-central-1) as well as dedicated deployments where data sovereignty is non-negotiable.
Yes. The eTMF and eISF live on the same governed data layer, so site and sponsor records stay in sync instead of drifting apart across separate systems.
See it on your own studies.
Book a 30-minute walkthrough. We'll look at how your TMF is set up today, show you the live completeness dashboard on a setup like yours, and map the fastest path to always-ready. No slides — just your operation.
- 30-minute call
- No slides, no obligation
- Tailored to your studies
Book your inspection-readiness walkthrough
Pick a time that works and tell us a little about your studies. We'll confirm within one business day.