Frequently asked questions
The short answers — each links to the full story.
What is Trialion?
The software a sponsor, CRO, or site uses to run the data side of a clinical trial: design the case report forms, open the sites, enroll participants, capture visit data, clean it with queries, verify it against source, sign it, and export it. See how a trial runs in Trialion.
How do I sign in? I was not given a password.
There are no passwords. You enter your email address and a six-digit code is sent to it, valid for five minutes. If you belong to more than one organization you pick one after entering the code; nobody is asked for a role at the door, because a role is held on a study. Full details, including what to do when a code fails, are in Signing in.
Why can't I change a value I already entered?
Because a field that already holds data is read-only until an open query authorizes the correction, and every change also needs a written reason. This is deliberate: it makes each correction traceable to why the data was questioned. What to do about it is in Correct data.
Why is a screen missing for me but visible to a colleague?
Three possible reasons: your role on that study does not include it, you are in a different workspace (Build, UAT and Live show different screens), or the study's state does not allow it yet. A person holds one role on each study, so check the role on the study you are looking at. See Finding your way around.
Which roles exist?
15 standard roles across three scopes: the whole organization, one study, one site. They cannot be edited, and an organization can compose custom roles from the same permissions under guardrails that refuse, for everyone, a permission the scope does not allow, the investigator-only permissions and combinations that break separation of duties. Browse them in Roles or read the full catalog.
How is data protected from tampering?
Every change is recorded per field with the old value, the new value, who, when, and why — in an append-only ledger where each entry is cryptographically chained to the one before it. Inserting, deleting, or editing an entry breaks the chain, and an auditor can run the verification themselves. Try the Audit Trail Explorer, or read Audit trail and evidence.
Can one organization see another's data?
No. Separation is enforced by the database itself, not only by the application — a query that forgot its tenant filter returns nothing rather than everything. Test and live data are kept apart the same way, by workspace. See Data and tenancy.
Is it ready for a regulated trial?
The controls are real — audit trail, reason for change, separation of duties, electronic signatures with re-authentication, versioned and sealed study design, two-person database lock. But no validation package is supplied, and several capabilities are absent, including randomization and blinding (a blinded study cannot be run), drug supply, medical coding, a safety gateway and a log of who read what. The complete list is in What is not built yet.
Which compliance frameworks does it address?
21 CFR Part 11, ICH E6(R3), ALCOA+, GAMP 5 / CSV, the overlapping requirements of HIPAA, GDPR and India's DPDP Act, and EU GMP Annex 11 in the clause matrices, each with what the software does and what remains your organization's. See the Compliance hub and knowledge base.
Are the diagrams and explorers accurate?
The role and permission data is generated directly from the platform's own catalog, so what you explore is exactly what the system enforces. The lifecycle explorers mirror the real state machines, and the module graph is read from the modules' own imports.
How do I find something specific?
Press ⌘K anywhere to search every page and heading, or browse by section in the sidebar.