Clinical trial transparency with every obligation in view.

Clinical trial transparency and disclosure teams use TrialAssure to run the full lifecycle on one platform: TrialAssure REGISTRY® for registration and results posting across 40+ registries, TrialAssure ANONYMIZE® for risk-based document anonymization, and TrialAssure LINK® AI for results and plain language summary drafting, with deadline tracking and audit proof built in. 8 of the top 10 clinical development companies use TrialAssure. It replaces the common mix of a registry-only tool, a separate anonymization vendor, spreadsheets, and email.

REGISTRY works from one dataset across 40+ registries and its rules engine auto-calculates each obligation — registration, results, updates, and anonymization windows — then recalculates remaining deadlines when a step completes early or late. The portfolio view puts every study’s status and upcoming deadlines on one dashboard, so nothing depends on a spreadsheet only one person maintains.

In the U.S., results-reporting violations under the FDAAA 801 final rule now carry civil monetary penalties of up to $15,107 per day (21 U.S.C. 333(f)(3)(B); the 2025-adjusted level, still current), and missed deadlines are increasingly flagged publicly on ClinicalTrials.gov. The point of a rules engine is to surface each deadline well before it’s urgent, so the answer is that you don’t reach the penalty stage. See our FDAAA 801 page for the specifics.

Yes — data migration is part of onboarding, not a separate project. We map your existing study records, submission histories, and open obligations into one dataset, then the rules engine recalculates the remaining deadlines for every trial, so nothing resets to zero. Historical submissions stay attached to the study, so the audit trail you have already built survives the switch. The honest limit is export quality: whatever your current tool cannot export cleanly has to be reconciled or re-entered, and we scope that with you before cutover rather than discovering it afterward. Your team keeps working while the migration runs alongside.

A registry-only tool covers registration and results posting; everything else on the disclosure critical path — anonymization, results drafting, plain language summaries, and the compliance evidence — sits with other vendors, and the handoffs between them are where deadlines slip. TrialAssure runs the full lifecycle on one platform: REGISTRY across 40+ registries, ANONYMIZE for risk-based anonymization, and LINK AI for results and summary drafting — one dataset, one rules engine, one audit trail. If your footprint is a single registry with no anonymization or plain language summary obligations, a point tool may be enough; the difference shows up the moment it is not.

Yes. ANONYMIZE performs risk-based, quantitative anonymization on the documents and datasets you publish — measuring re-identification risk against the applicable threshold rather than blacking out pages — and generates the documentation behind your anonymization report. It processes documents up to 80% faster, which matters because a stalled anonymization queue is what turns a manageable posting deadline into a missed one. The same defensible methodology serves CTIS, EMA Policy 0070, and Health Canada PRCI, so one risk position works across jurisdictions. The threshold and its justification stay your decision: specialists review the output, and every transformation is logged and attributable.

Start with what you can actually staff, and change the mix later. Three models run on the same platform: license it and run disclosure yourself, run it alongside our transparency specialists, or hand us the portfolio while you rebuild the team. Because the work happens in one system either way, moving between models changes who holds the queue rather than requiring a migration, and the audit trail stays continuous through the handover. That is the difference from scoping a fresh services engagement each time, which restarts context you already paid for. See Services.

Every submission, field change, approval, and timestamp is logged and attributable to a named user, so the evidence an inspector asks for already exists instead of being reconstructed from email and file shares after the notice arrives. That includes anonymization decisions and the risk documentation behind them, so an anonymization position can still be explained years later by someone who was not in the room. The same record is presented at portfolio level: status per study, what was submitted where, and when. Underneath, TrialAssure is ISO 9001:2015 and ISO/IEC 27001:2022 certified, GDPR-aligned and HIPAA-aligned — the Trust Center has the full posture.

No. TrialAssure is AI Enabled. Human Driven.™ — the software takes the mechanical work, your team keeps the judgment and the accountability. LINK AI drafts results summaries and plain language summaries inside Microsoft Word on your own templates, with source references at statement level, so review is verification against the source rather than rewriting from a blank page. The rules engine surfaces deadlines, but a person approves every submission, and every transformation is logged and attributable. What changes is where your writers spend time: less first-draft assembly and re-keying, more local-language adaptation, scientific judgment, and review.

Our clinical trial transparency specialists monitor the registries and turn each change into an updated rule, so a new field, a changed format, or a shifted clock is maintained centrally instead of being something your team has to discover, interpret, and re-teach itself. Because all 40+ registries work from one dataset and one engine, an updated rule immediately shows which of your studies it touches and recalculates the deadlines it moves — you see the change and its portfolio impact in the same place. Registries do sometimes change with little notice; the engine shortens the gap between the change and your response rather than pretending it away.

Yes. The platform is modular, so you can start with your worst bottleneck: registration and results posting in REGISTRY, or the anonymization queue in ANONYMIZE, adding LINK AI when drafting volume becomes the constraint. Because every module works from the same study dataset and writes to the same audit trail, expanding later means enabling the next part of the lifecycle — not a second integration, a second migration, or a second vendor relationship. Nothing you configure in the first phase has to be rebuilt for the next one.

8 of the top 10 clinical development companies use TrialAssure. The delivery record behind that: 8 million+ pages of documents, 400+ clinical datasets, and 850,000+ pages anonymized with Certara across 250+ projects. On timeliness, customers improved their performance against the 21-day registration target by 50%. Daiichi Sankyo’s plain language summary delivery ran up to 80% faster at ~50% lower cost per document. Results vary by portfolio mix, registry footprint, and review policy — “up to” is the ceiling, not the average. More in our case studies.