Clinical trial software powered by purpose-built AI.

TrialAssure® is AI-powered clinical trial software that helps teams anonymize and share data and documents, draft content that your writers sign off on, register trials, and prove compliance. Our technology helps move the work faster, backed by people who understand the regulations and know what it takes to get it right.

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Trusted on both sides of the submission, by the sponsor and CRO teams who file and the agencies that publish.

Founded 2009

WRITE: ANONYMIZE: REGISTER:

PRM001 Zinon · Regax, Inc. Source record

✓ Approved Source · adverse events

…a 57 year old55–59 year-old male, first dosed 20 Jan 2025Day 1…

0.09

ClinicalTrials.gov CTIS ANZCTR + 37 more

Trusted by life sciences teams and regulatory authorities worldwide

News Jul 28, 2026 TrialAssure^® ANONYMIZE^® Selected by the European Medicines Agency as Official Anonymisation Tool

Who does this work

Technology should make expertise more valuable.

Give your experts better starting points, faster reviews, and fewer manual tasks. TrialAssure uses purpose-built AI to move the work forward and allows your team to maintain control of the decisions, context, and judgment that clinical trial technology can’t replace.

WHY NOW

Transparency regulations change. Your confidence shouldn’t.

Global requirements continue to evolve across the FDA, EMA, EU CTR, Health Canada and other authorities. New expectations bring new workflows, deadlines and decisions for teams already managing complex clinical programs. TrialAssure combines purpose-built clinical trial transparency software with people who understand the regulations, helping teams respond with confidence and keep critical work moving.

TrialAssure was built for today’s requirements and is ready for what’s next.

280 hours: what manual assembly of one clinical study report can take
0.09: EMA and Health Canada's re-identification risk threshold for anonymized documents
12 months: EU CTR clock for results and a lay summary — 6 for pediatric trials
$15,107: maximum daily U.S. penalty for results-reporting violations

THE PLATFORM

Better technology for medical writing, anonymization and clinical trial transparency.

Backed by multiple granted patents, with a plain language summary patent pending, AI-assisted medical writing, advanced anonymization and redaction, and global clinical trial registration and disclosure come together in one platform built for today’s regulatory requirements.

Draft & write

Draft technical and non-technical documents inside Microsoft Word, including CSRs, protocols, narratives, plain language summaries, and others, in days, not weeks.

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Plain language summary Approved

Source · adverse events

Event	Placebo	Zinon
Nasopharyngitis	8/107	10/104
Fatigue	3/107	6/104
Constipation	0/107	4/104

Generated summary

The most common side effect was a common cold, reported by 10 of 104 people taking Zinon and 8 of 107 people taking placebo.

✓ Approved — medical writer

Protect & share

Regulatory-grade, risk-based clinical data anonymization for documents, datasets, and images to protect identities and keep the science usable.

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Output · patient narrative Anonymized ▶ Process Document

Patient No. PRM001-01-111, a 57 year olda 55-59 year-old white male, treated with placebo, first dosed 20 Jan 2025Day 1 at Novidane, ND 58105[City, ND], experienced worsening allergic reaction to contrast dye.

Clinical trial disclosure software for registering trials and disclosing results across 40+ global registries from one system, with a rules engine that knows every deadline.

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Protocol registration Accepted Release

Study identification
Study status
Sponsor
Oversight
Description
Conditions
Design
Eligibility

Protocol ID PRM001 6/30

NCT Number NCT0XXXXXXX 11/11

Organization Regax, Inc. 11/60

Brief Title Physiological Magnesium Maintenance in Chronic Renal Disease Subjects Requiring Dialysis by Delivery of Zinon via Hemodialysate 127/300

Study Type Interventional 14/20

Simulated product interface · fictional study data (“Zinon”, Regax Inc.)

Beyond pharma: the same engine cuts government FOIA backlogs by up to 80% — powered by Trusano.

AI executes. People stay accountable.

Clinical trial software delivered at scale, on the record.

8/10: top clinical development companies use TrialAssure
Up to 90%(see source note): error reduction in anonymization deliverables
40+: global registries covered from one system
850,000+: pages anonymized with Certara alone
15+: years in trial transparency and disclosure
Patented software: Including date-offset anonymization; plain language summary patent pending

* Results vary by program; all AI output is human-verified.

Proof

Three products. Proven in practice.

Daiichi Sankyo · Case study

Daiichi Sankyo pairs LINK AI drafting with TrialAssure’s medical writers — and ships regulatory documents faster, at lower cost.

Up to 80%: faster document delivery
~50%: lower cost per document

Read the Daiichi Sankyo case study →

Certara · Case study

A service provider licensed ANONYMIZE and runs it inside its own client delivery

850,000+: pages
250+: projects

Read the case study →

AI-powered data anonymization for documents and datasets

REGISTRY

Meet REGISTRY, the clinical trial registry platform

40+: global registries covered from one system

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Technology to simplify clinical trial registration and results disclosure

Cancer Research UK’s Centre for Drug Development uses LINK AI to draft regulatory and clinical trial documents — with its own medical writers central to every review.

Centre for Drug Development, Cancer Research UK

The flexibility in workflow makes it a tool easily implemented in just about any organization.

Associate Director

TrialAssure is the perfect partner in this space. Their AI knowledge and their AI-enabled software will allow us to co-create a solution that doesn’t exist in the market today.

Senior Director, clinical research organization (CRO)

Award-winning technology, featured across the life-science press

Clinical trial software: run it yourself, run it with us, or hand it to us.

License the platform

Your team, our clinical trial software. Full control, full audit trail.

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Run it with our experts

Your process, our specialists working alongside to bring greater capacity when deadlines stack.

Talk to our team

Clinical trial disclosure as a service

Hand us the requirement. Our team runs the clinical trial disclosure software for you and delivers the compliant output; you maintain oversight.

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AI Enabled. Human Driven.™

Every transformation logged. Every decision traceable. Every record inspection-ready by design.

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ISO 9001:2015 Quality management, certified
ISO/IEC 27001:2022 Information security at its highest level
GDPR EU operations, TrialAssure B.V. (Eindhoven)
Award-winning Data Breakthrough Awards · Int’l Best in Business · MichBusiness

AI
AI does the heavy lifting

First drafts, redactions, registry submissions — the repetitive work, compressed from weeks to minutes.
Human
Specialists verify every output

People who know the regulations review AI work before anything ships — supporting writers, never replacing them.
AI
The system keeps the record

Each transformation and decision is captured as it happens — nothing reconstructed after the fact.
Human
You sign off, inspection-ready

Final accountability stays with people, with a defensible audit trail behind every call.

Transparent Thinking

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The dome of the United States Capitol at dusk with an American flag

Blog · October 7, 2026

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Regulatory changes, deadlines, and practical guidance — no noise.

See the whole lifecycle on one platform.