Your trials deserve a TMF that runs itself.

Your trials deserve a TMF that runs itself.

Your trials deserve a TMF that runs itself.

Instead of managing documents across email threads and shared drives, with a system that was never designed to scale, deploy our AI Teammate to run your TMF and watch your backlog hit zero.

etmf status

etmf status

Struggling to stay on top of your eTMF or just starting?

Struggling to stay on top of your eTMF or just starting?

Struggling to stay on top of your eTMF or just starting?

Struggling to stay on top of your eTMF or just starting?

Start your trial right. Not the manual way.

If you need an eTMF, you get Tilda’s AI-native repository and the AI Teammate together as one package.

Tilda’s AI-Native eTMF

AI Teammate included, not bolted on.

Document classification, QC, completeness monitoring, and automated work orders are built into the system. The AI Teammate and the repository are the same product. There’s no integration layer to manage.

Validated, compliant eTMF, out of the box

Pre-configured to the DIA 3.3.1 TMF Reference Model. SOC 2 Type II, FDA 21 CFR Part 11, HIPAA, and GDPR compliant. Inspection-ready from day one, not day 90. No separate implementation project.

Deploys in ~2 weeks

You provide your TMF index, TMF plan, and any QC requirements. Tilda handles training, validation, and deployment. No IT project. No change management marathon. Designed for lean teams at IND or study start.

Scales across your study portfolio without re-implementing

Each new study reuses the same AI training with minor customization; a few hours of configuration, not a new implementation. One AI Teammate, multiple studies, compounding accuracy over time.

Your data stays yours

Fully isolated instance per customer. Your documents are never co-mingled with another customer’s data and are never used to train shared models. Zero data retention policy available by contract.

"Why would we use that old TMF when this is so much better and the AI Teammate is already built in?"

Biotech customer
(Clinical-stage Oncology), 2026

Switched away from their existing eTMF vendor after seeing Tilda's native eTMF in production.

RESULTS

Already working at scale

8 weeks

to complete 6 months worth of TMF work

98% vs. 74%

That's our AI Teammate's filing accuracy vs. human reviewers

up to 72%

TMF workflow cost reduction validated across deployments

94%

AI work acceptance rate in a live trial

8 weeks

to complete 6 months worth of TMF work

up to 72%

TMF workflow cost reduction validated across deployments

98% vs. 74%

That's our AI Teammate's filing accuracy vs. human reviewers

94%

AI work acceptance rate in a live trial

The TMF AI Teammate

Forget dashboards and assistants.
Our AI Teammate gets the work done.

AI assistants and dashboards tell your team what's missing. The TMF AI Teammate finds issues, flags them, creates work orders, and closes the loop, without your team managing the queue. This applies whether Tilda is your eTMF or sits on top of one you already have.

01

Automated classification & filing

Every document is classified against your TMF index and placed in the correct section automatically. 98% accuracy in production with no sampling, no fatigue, and no Friday afternoon errors.

02

Continuous QC against ALCOA+ standards

QC runs on ingestion, not monthly cycles. Signatures, metadata, completeness, and cross-document consistency are checked on every document. QC findings drop from 40–60% to under 3%.

03

Active completeness monitoring (EDL)

The AI Teammate tracks expected vs. filed documents by zone, section, and sub-artifact. It doesn't wait for a query; it flags gaps before they become inspection findings.

04

Automated work orders & resolution

When a gap is found, a structured work order goes to the right person, site, CRA, or study team. No email chains. No manual chasing. Your team handles exceptions; the AI Teammate handles the volume.

05

Human oversight, always

Low-confidence tasks escalate to your team before filing. Nothing auto-approves without a defined escalation path. Full audit trail on every action, and explainable on inspection day.

06

Agentic AI, not generative

No chatbot. No hallucinations. Tilda's AI Teammates use deterministic, agentic execution: each action logged, each decision traceable. This is what earns trust in regulated environments.

01

Better data quality and faster timelines

Extensive automation results in demonstrably better data quality and faster timelines.

02

Real-time Centralized Monitoring 

Access secure, live data instantly for effective trial oversight and decision making.

03

Seamless Regulatory Compliance 

Ensure global compliance and maintain inspection readiness with built-in adherence to international guidelines.

02

Real-time Centralized Monitoring 

Access secure, live data instantly for effective trial oversight and decision making.

03

Seamless Regulatory Compliance 

Ensure global compliance and maintain inspection readiness with built-in adherence to international guidelines.

03

Seamless Regulatory Compliance 

Ensure global compliance and maintain inspection readiness with built-in adherence to international guidelines.

01

Better data quality and faster timelines

Extensive automation results in demonstrably better data quality and faster timelines.

02

Real-time Centralized Monitoring 

Access secure, live data instantly for effective trial oversight and decision making.

03

Seamless Regulatory Compliance 

Ensure global compliance and maintain inspection readiness with built-in adherence to international guidelines.

02

Real-time Centralized Monitoring 

Access secure, live data instantly for effective trial oversight and decision making.

03

Seamless Regulatory Compliance 

Ensure global compliance and maintain inspection readiness with built-in adherence to international guidelines.

03

Seamless Regulatory Compliance 

Ensure global compliance and maintain inspection readiness with built-in adherence to international guidelines.

the time to INVEST

The moments that make you act.

Start inspection-ready.

Tilda gives you a validated eTMF and the AI Teammate in ~2 weeks. No catch- up remediation later.

the verdict

"Every metric has been improved by using your system. It's made a direct and immediate impact faster startup, lower queries, inspection-ready from day one."

George Magrath, MD

CEO, Opus Genetics

Data Security

We lead with security.

Your clinical documents are some of the most sensitive data in your organization. That's why we take security seriously.

Fully isolated instance per customer

Your documents are never co-mingled with another customer's data.

Zero data retention by contract

Documents deleted from Tilda after processing and sync, if that's your requirement.

Your data never trains shared models

Model training happens in Tilda's segregated, validated environment. No cross-contamination.

Customer sign-off on all model changes

Batched updates, structured SDLC, your approval before any change goes live.

GxP validation package available

IQ/OQ/PQ documentation available under NDA for QA-led procurement
processes.

Compliance logo
FDA 21 CFR Part 11
Compliance logo
SOC 2 Type II
Compliance logo
HIPAA
Compliance logo
GDPR
Compliance logo
GCP Aligned

first engagement TO full DEPLOYMENT

You set the bar.
We clear it.

We agree on accuracy benchmarks upfront for an initial engagement. When we hit them, the full rollout continues automatically.

1Baseline
2Run-in
3Readout

Set the benchmark

Pre-agreed accuracy targets are set against your existing process before we start. If we don't hit them, there's no commitment to go live.

Day 0

Run on your real documents

We run on your actual documents, not a demo dataset. Your team reviews the AI Teammate's outputs and provides accept/reject feedback. No technical involvement required.

1-4 Weeks

Smooth transition to production

Benchmarks hit = go-live continues automatically.

Common Questions

Things you're probably thinking about.

We don't have an eTMF yet. Is Tilda's built-in TMF actually production- grade for a regulated trial

Yes. Tilda's native eTMF is a fully validated, compliant document repository — not a staging tool. Multiple clinical-stage biotechs have run their active trials in it, presented results at major conferences, and passed regulatory reviews without findings.

We already use Veeva / Prevail / Wingspan. Do we have to replace it?

No. The AI Teammate integrates via API. Your existing eTMF stays the system of record. Some customers start in integration mode and later consolidate onto Tilda's native TMF — but that's never a requirement upfront.

Does using Tilda mean managing documents across two systems?

No. Documents enter Tilda once. The AI processes them; the approved version syncs automatically to your eTMF. Your team doesn't touch the same document in two places. The staging step is invisible in practice.

We're a lean team. Will implementation be a burden?

Tilda manages all training, validation, and deployment. Phase Zero takes 2–4 weeks. Your team provides accept/reject feedback on AI outputs — not technical work. Designed for lean teams at exactly this stage of a trial.

We have someone manually handling TMF right now. What happens to them?

Their role shifts from execution to oversight. Instead of filing documents and chasing emails, they manage the AI's exception queue and focus on the judgment calls that genuinely need clinical knowledge. Most teams find that person becomes more valuable, not redundant.

What if the AI makes a documentation error?

The AI does not auto-approve its own output. Low-confidence tasks escalate to your team before entering the TMF. Production accuracy is 98% — higher than human reviewers — but the human oversight layer is structural, not optional. Full audit trails on every action.

Have an AI Teammate run your TMF

Not a slide deck. Not a conceptual walkthrough. We'll show you the TMF AI Teammate executing work on a real workflow, in real time.

If you don't have an eTMF, we'll show you both the repository and the AI Teammate together. 30 minutes. No obligation.

Not a slide deck. Not a conceptual walkthrough. We'll show you the TMF AI Teammate executing work on a real workflow, in real time.

If you don't have an eTMF, we'll show you both the repository and the AI Teammate together. 30 minutes. No obligation.

Book a Demo

©2026, Tilda Research. All rights reserved.

©2026, Tilda Research. All rights reserved.

©2026, Tilda Research. All rights reserved.

©2026, Tilda Research. All rights reserved.