40+ registries. One system. Every deadline visible.

REGISTRY covers 40+ registries globally, including ClinicalTrials.gov and EU CTIS, with the full list available on request. Each clinical trial registry is treated as its own ruleset rather than one generic form: distinct data fields, validation rules, update triggers, and clocks that start from different events — first participant enrollment at one registry, authorization or completion at another. The rules engine is updated as registries change their requirements, so each submission is prepared against that registry’s current ruleset rather than a generic internal checklist. Coverage is registration, updates and results posting — not scientific review of the content you submit.

FDAAA 801 requires registration within 21 days of first participant enrollment and results within 12 months of primary completion, all filed through the ClinicalTrials.gov PRS. REGISTRY tracks both clocks per study automatically, derived from the study record rather than a manually maintained calendar, and surfaces studies approaching a date instead of reporting the miss afterwards. The penalty math is why this matters: U.S. fines now run up to $15,107 per day. Deadlines are not always fixed — the regulation allows certified delays for some results submissions — so the engine tracks the date that actually applies to each study and leaves the filing judgment to your disclosure specialists.

Yes — study information flows in from your CTMS or data warehouse via API, and deadline-driven workflows flow back out, so you enter data once instead of re-keying it across systems. Field mapping is configured to your data, which means the rules engine reads the same study record your operations team already maintains — identifiers, sites, enrollment events, completion dates — and derives per-registry requirements from it. Where no integration exists, studies can be entered directly in the portal instead. Either way, every submission, timestamp and change is logged, so the audit trail survives the handoff between systems.

Yes — REGISTRY handles EU CTR requirements through CTIS, including the transparency rules and results timelines. EU CTR trials sit alongside your other registries, so the application, substantial modifications and results postings share one queue with their deadlines visible. CTIS is unusual in that publication is part of the submission: what becomes public, and when, depends on the trial category and the deferral rules that apply to it, so the answer is a per-trial determination rather than a single date. See the EU CTR / CTIS requirement page for the full mapping.

The rules engine is updated centrally. Your open studies re-evaluate against the new requirement — no spreadsheet archaeology. You do not maintain your own copy of the regulation, reissue an SOP, or rediscover by hand which studies were affected: the change lands once, and the deadlines and required fields across your portfolio move with it. The engine is maintained against current regulation, and TrialAssure publishes Registry Snapshots tracking global requirements. Where a change alters what you must disclose rather than only when, REGISTRY flags the affected studies and disclosure specialists review the edge cases so your team makes the call.

Yes. Results prepared in REGISTRY hand off to TrialAssure ANONYMIZE for defensible de-identification, so registration, anonymization, and disclosure run as one workflow instead of three disconnected ones. Nothing is re-keyed between them: the study record, the document set and the disclosure deadline carry across, and the anonymization decisions — what was redacted or transformed, under which rule, reviewed by whom — are logged against the submission they support. That is what you need years later, when a regulator questions a redaction and the specialist who made the call has moved on.

Yes — REGISTRY is the platform we customize. Registry requirements differ by country and agency, and the engine was built for that variance: organizations have engaged us to configure it per registry, extend it with AI-assisted protocol-field extraction, and build branded clinical trial registry platforms on it as a base. If your requirement goes beyond the product, talk to us.