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AI Foundations for Clinical Research Leaders

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Let AI Teammates
run ClinOps

Unlock new levels of your team's productivity and organization's potential by deploying Tilda's AI Teammates. They execute workflows end-to-end and are inspection-ready by default.

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See how it works

Works inside your existing eClinical stack.

Agentic AI that executes with your team's full oversight.

Fully deployed to live trials within weeks.

Trusted by world-class sponsors, CROs, and biotechs

The problem with clinical ops

More trials. More coordinators.
More handoffs. The bottleneck
is at breakpoint.

For decades, clinical operations has scaled by adding more people. With AI-designed drug development compounding the operational bottleneck, a new approach is now essential.

A model no longer fit for purpose

Scale by headcount

When workload increases, hire more coordinators and support staff to keep work moving.

Work moves through people

Tasks pass hand-to-hand across systems, generating follow-ups and endless status meetings.

Progress tracked, not completed

Software shows where the work is. Humans still have to move it.

Cost scales with complexity

More trials, more cost. The model reinforces itself at every turn.

Inspection readiness is an afterthought

When an FDA or EMA inspector arrives, your TMF is only as clean as the last person who touched it. Manual processes leave gaps that no one finds until it's too late.

The Tilda Research model

Work completes itself end-to-end

AI Teammates act, not just inform. Workflows run autonomously inside your existing stack.

Scale with AI Teammates

AI takes on execution. Your team scales for judgment, not busywork.

Execution-driven, not coordination-driven

Teams focus on oversight and decisions. The execution layer handles itself.

Inspection-ready by design

Every document action is logged, traceable, and audit-ready. Your TMF is continuously maintained to inspection standard, not cleaned up before an inspection.

We believe clinical operations should execute work, not coordinate it. The future isn't better coordination. It's eliminating the need for it entirely.

128

A model no longer fit for purpose

Scale by headcount

When workload increases, hire more coordinators and support staff to keep work moving.

Work moves through people

Tasks pass hand-to-hand across systems, generating follow-ups and endless status meetings.

Progress tracked, not completed

Software shows where the work is. Humans still have to move it.

Cost scales with complexity

More trials, more cost. The model reinforces itself at every turn.

Inspection readiness is an afterthought

When an FDA or EMA inspector arrives, your TMF is only as clean as the last person who touched it. Manual processes leave gaps that no one finds until it's too late.

The Tilda Research model

Work completes itself end-to-end

AI Teammates act, not just inform. Workflows run autonomously inside your existing stack.

Scale with AI Teammates

AI takes on execution. Your team scales for judgment, not busywork.

Execution-driven, not coordination-driven

Teams focus on oversight and decisions. The execution layer handles itself.

Inspection-ready by design

Every document action is logged, traceable, and audit-ready. Your TMF is continuously maintained to inspection standard, not cleaned up before an inspection.

We believe clinical operations should execute work, not coordinate it. The future isn't better coordination. It's eliminating the need for it entirely.

128

A model no longer fit for purpose

Scale by headcount

When workload increases, hire more coordinators and support staff to keep work moving.

Work moves through people

Tasks pass hand-to-hand across systems, generating follow-ups and endless status meetings.

Progress tracked, not completed

Software shows where the work is. Humans still have to move it.

Cost scales with complexity

More trials, more cost. The model reinforces itself at every turn.

Inspection readiness is an afterthought

When an FDA or EMA inspector arrives, your TMF is only as clean as the last person who touched it. Manual processes leave gaps that no one finds until it's too late.

The Tilda Research model

Work completes itself end-to-end

AI Teammates act, not just inform. Workflows run autonomously inside your existing stack.

Scale with AI Teammates

AI takes on execution. Your team scales for judgment, not busywork.

Execution-driven, not coordination-driven

Teams focus on oversight and decisions. The execution layer handles itself.

Inspection-ready by design

Every document action is logged, traceable, and audit-ready. Your TMF is continuously maintained to inspection standard, not cleaned up before an inspection.

We believe clinical operations should execute work, not coordinate it. The future isn't better coordination. It's eliminating the need for it entirely.

128

A model no longer fit for purpose

Scale by headcount

When workload increases, hire more coordinators and support staff to keep work moving.

Work moves through people

Tasks pass hand-to-hand across systems, generating follow-ups and endless status meetings.

Progress tracked, not completed

Software shows where the work is. Humans still have to move it.

Cost scales with complexity

More trials, more cost. The model reinforces itself at every turn.

Inspection readiness is an afterthought

When an FDA or EMA inspector arrives, your TMF is only as clean as the last person who touched it. Manual processes leave gaps that no one finds until it's too late.

The Tilda Research model

Work completes itself end-to-end

AI Teammates act, not just inform. Workflows run autonomously inside your existing stack.

Scale with AI Teammates

AI takes on execution. Your team scales for judgment, not busywork.

Execution-driven, not coordination-driven

Teams focus on oversight and decisions. The execution layer handles itself.

Inspection-ready by design

Every document action is logged, traceable, and audit-ready. Your TMF is continuously maintained to inspection standard, not cleaned up before an inspection.

We believe clinical operations should execute work, not coordinate it. The future isn't better coordination. It's eliminating the need for it entirely.

128

Validated results

Proof, not promises.

72%

Maximum TMF workflow cost reduction validated across deployments

98%

vs. 74% for human reviewers

That's our AI Teammate's filing accuracy

8 weeks

to complete 6 months worth of TMF work

94%

AI work acceptance rate in a live trial

71

Errors missed by the CRO human team — caught by AI

Numbers sourced from active customer deployments. We don't use projections.

72%

Maximum TMF workflow cost reduction validated across deployments

98%

vs. 74% for human reviewers

That's our AI Teammate's filing accuracy

8 weeks

to complete 6 months worth of TMF work

94%

AI work acceptance rate in a live trial

71

Errors missed by the CRO human team — caught by AI

Numbers sourced from active customer deployments. We don't use projections.

How it works

Deploy an AI Teammate.

Watch the work disappear.

Deploy an AI Teammate.

Watch the work disappear.

No rip-and-replace. AI Teammates drop into your existing systems, eTMF, EDC, and start executing immediately.

1Setup

2Autonomy

3Oversight

Map the workflow

We configure an AI Teammate around your trial protocols, SOPs, and existing tech stack within 2 weeks. No new platform to learn.

Day 0

Deploy and run

The Teammate begins executing work autonomously — classifying, filing, resolving queries — inside your environment from day one.

1-4 Weeks

Your team leads

Your people focus on judgment, oversight, and decisions. Every action logged, every document traceable, and your TMF maintained to inspection standard without anyone staying late to prepare for it.

2-4 Weeks

Start deployment

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.

FDA 21 CFR Part 11

SOC 2 Type II

HIPAA

GDPR

GCP Aligned

Ready to work

Your AI Teammates

Purpose-built for clinical operations. Each Teammate executes a specific function end-to-end — without human handholding.

Trial Master File

Live

Classifies, QCs, and files your TMF documents at 98% accuracy — 15x faster than a human team. When a document needs correction, it emails the site, manages the back-and-forth, escalates when stuck, and files the resolved document without a coordinator in the loop. Works with any eTMF: Veeva, Viva, SharePoint, Box. Supports 90+ languages. Inspection-ready by design.

Site & Study Management

Live

Manages the full study startup process and ongoing site maintenance. Collects essential document packages, handles IP release packages, submits protocol amendments, and manages all site communications — replacing the coordination layer that typically requires a dedicated team of startup specialists and CRAs.

Study Monitoring

Coming soon

Takes on the work of an in-house CRA or data manager. Manages outstanding issues from monitoring visits, raises queries, tracks enrollment, and handles all the follow-up work that currently sits between your team and the sites.

Finance & Payments

Coming soon

Manages all clinical trial financial operations — site payments, vendor invoices, and contract reconciliation. Every dollar in or out, executed against the contract. Raises invoices, sends them, and tracks payment status without a finance coordinator in the loop.

Who it's for

Whether you're running
trials or running a CRO.

Margin pressure doesn't stop. Headcount costs do.

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

-37%

Cost per study

Case study

From backlog to inspection-ready
in 8 weeks.

No rip-and-replace. AI Teammates drop into your existing systems, eTMF, EDC, and start executing immediately.

A fast-growing gene therapy CRO facing a critical TMF backlog.

Perceive Bio had a mounting TMF remediation problem — the kind that typically means months of painful manual catch-up, temporary staffing, or both. Instead, they deployed Tilda's TMF AI Teammate.

The Teammate classified and filed documents at 98% accuracy, working autonomously inside their existing eTMF environment. No new systems. No contractor ramp-up. Work that ran itself.

Read the full case study

72%

Cost reduction on TMF ops

8 wks

vs. 6-month projection

98%

Classification accuracy

0

New hires required

the verdict

"We've been talking about AI in clinical ops for years. Tilda Research is the first company I've seen that's actually doing the work, not describing it."