Trial360 OS
The Science is the hard part. The Platform shouldn't be.
One platform for sponsors, CROs, investigator sites and participants. Built for 21 CFR Part 11, with every change on the audit trail and AI that only suggests. People decide.
Designed for 21 CFR Part 11 · EU GMP Annex 11 · ICH E6(R3) · TMF Reference Model 3.3
The platform
One platform for everyone who runs the trial.
Sponsors, CROs, sites and participants each get a module built for their work. Each module keeps its own records, on the same foundation of access control, audit trails and compliance rules.
For sponsors and CROs · TMF360
A trial master file that stays inspection-ready.
- Filed to TMF Reference Model 3.3.1 at trial, country and site level
- QC review and e-signature before any document becomes Final
- Missing and overdue records shown beside filed ones, by country and site
- Inspection Mode gives an auditor a time-limited, read-only view
For investigator sites · Site360
The site file, ready for the monitor's next visit.
- Investigator Site File organised by zone, with review and approval
- Readiness score and gap analysis that name the missing core documents
- Staff, delegation log and training kept with the study
- Monitoring visits, tasks and queries in one place
Screens from a demo study. The sponsor, study, site and people are fictional.
For participants · Participant360
A study portal participants can actually use.
Their study journey, daily diaries, questionnaires and upcoming visits, in plain language and in English or Spanish.
Open the portal →For patients · TrialFinder360
Help patients find a trial that fits.
Search recruiting trials from ClinicalTrials.gov, read them in plain language and see who to contact.
Find a trial →Compliance
The controls an inspector expects, built in.
These are enforced by the database itself, not by screens that could be bypassed. The evidence for each one is on our Trust page.
| Control | How Trial360 handles it |
|---|---|
| Audit trail | TMF360 and the Site360 ISF record every change with who, what and when. Entries are hash-chained and append-only, so they cannot be altered or removed. |
| Electronic signatures | In TMF360, signing requires the user's password again and records the meaning of the signature, as 21 CFR Part 11 requires. |
| Record retention | Records are never hard-deleted. In TMF360, deletions need a coded reason, Final records need a second person's signed approval, and legal holds block deletion entirely. |
| Timestamps | All times come from the server. The browser can never set when something happened. |
| Access | Access is granted per organisation, study and site, and enforced by row-level security in the database. |
| File integrity | TMF360 fingerprints every file with SHA-256 on upload and re-checks it, so duplicates and changes are detected. |
Roadmap
More modules on the way.
Planned modules, built on the same foundation. Ask us about timing for your study.
Architecture
One foundation. Independent modules on top.
Modules never read or write each other's records. What they share is the foundation underneath, so every one follows the same rules.
Modules
TMF360, Site360, Participant360 and TrialFinder360, each with its own workflows, data and screens.
Trial360 OS core
Organisations, studies and roles, access control, tamper-evident audit trails and AI with human approval.
Integrations
A REST ingestion API today. EDC, CTMS and CDISC connectors are on the roadmap.
See it with a study like yours.
A walkthrough of the platform with your questions answered, including how validation would work for your organisation.