AI Technology Built for Today’s Clinical Trial Regulations
TrialAssure® combines purpose-built technology with deep regulatory expertise to help teams address clinical trial disclosure requirements, medical writing, anonymization, registration, and disclosure.
By team
Medical Writing teams
AI-assisted medical writing that gives writers more capacity and keeps their expertise at the center.
Learn more →Transparency & Disclosure teams
Registration, results, and documents meeting clinical trial disclosure requirements across global registries.
Learn more →Legal, Privacy & Compliance
Defensible anonymization with a full audit trail for clinical trial compliance.
Learn more →CROs & Service Providers
Purpose-built technology and expertise you can bring into your own client delivery.
Learn more →Government
Patented anonymization technology for FOIA and public-records review beyond clinical research.
Learn more →By clinical trial disclosure requirement
EMA Policy 0070
Risk-based anonymization and reporting for clinical documents and data prepared for public release.
Learn more →EU CTR / CTIS
Support for trial registration, results, documents, and transparency requirements through CTIS.
Learn more →FDAAA 801 / ClinicalTrials.gov
Registration, updates, and results disclosure on time, portfolio-wide.
Learn more →Health Canada PRCI
Risk-based anonymization for the public release of clinical information.
Learn more →Plain Language Summaries
AI-assisted drafting that helps medical writers create clear, accessible summaries.
Learn more →Choosing a solution — FAQ
Should I start from my team or from the clinical trial compliance requirement?
Whichever is more pressing. If a regulator has set your date, start from the clinical trial disclosure requirements — those pages carry the authority, the legal basis and every deadline with its citation. If you own the work rather than the date, start from your team. The two routes cover the same platform, so you lose nothing by picking one and arriving from the other side.
What if several clinical trial transparency regulations apply to the same study?
Overlapping clinical trial transparency regulations are the normal case, and the argument for one platform rather than a tool per obligation. A study is entered once and mapped to each registry it is subject to, anonymization and drafting run against the same records, and a single audit trail covers all of it. The platform overview shows how the products fit together.
Which products sit behind these solutions?
Three: ANONYMIZE for risk-based anonymization of documents and datasets, LINK AI for drafting inside Microsoft Word on your own templates, and REGISTRY for registration and disclosure across 40+ registries from one system, with every obligation and deadline tracked from that same record. Government records teams use Trusano — the same anonymization engine, configured for public records rather than clinical documents.
Is TrialAssure only for pharmaceutical sponsors?
No. Sponsors and biotechs are the core, CROs deliver the same work under their own brand, and public-sector records teams use Trusano for FOIA and public-records review. The engine underneath is the same in each case; what changes is the record types and the rules it is configured against.
We are a CRO rather than a sponsor — where do we start?
With CROs and service providers, which covers delivering under your own brand and engagement model, keeping each sponsor’s data separate, and the economics of platform-rate throughput. Partner programs covers the commercial models.
How do I choose the right TrialAssure solution?
Start by requirement if a regulation is driving your timelines. EMA Policy 0070, EU CTR, FDAAA 801, Health Canada PRCI and plain language summaries each have dedicated resources covering requirements and key deadlines. Start by team if you are looking for solutions built around the work your team manages. Both routes help you find the TrialAssure technology and expertise that fit your needs.
What the requirement pages give you
Each page brings the relevant regulatory information together, including the authority, legal basis, deadlines, and submission requirements. For EU CTR / CTIS, FDAAA 801, and plain language summaries, calculators can also turn study dates into applicable due dates. Explore EMA Policy 0070, EU CTR / CTIS, FDAAA 801 / ClinicalTrials.gov, Health Canada PRCI, or plain language summaries.
What the team pages give you
Each page focuses on the priorities and responsibilities of a specific team, including where technology can reduce manual effort, support better decisions, and make existing expertise more valuable. Explore medical writing, transparency & disclosure, legal, privacy & compliance, CROs and service providers, or government records teams.
Most portfolios involve several clinical trial regulations
Registration, anonymization, plain language summaries, and medical writing often intersect across a clinical development program. TrialAssure gives teams the flexibility to address an immediate need with a purpose-built product and connect additional capabilities when it makes sense. Study information can carry across TrialAssure REGISTRY®, TrialAssure ANONYMIZE®, and TrialAssure LINK® AI, reducing duplicate work and creating greater continuity across the clinical trial lifecycle.
Rather we run it? Tell us the studies and the deadline.
Name the capability and the shape of the work: how many studies or documents, which registries are in scope, and the date driving it. Whether that is anonymized clinical reports with the anonymisation report, CTIS and ClinicalTrials.gov submissions, PRCI, or plain language summaries, we come back with who would run it, what it takes, and how fast we can start. A specialist replies within one business day.
Tell us which clinical trial regulations apply. We’ll show the fit.
Deep regulatory expertise behind every TrialAssure product.