Trialion CDMS is an electronic data capture (EDC) and clinical data management system. It is where a clinical trial's data lives, from the first case report form a designer draws to the locked dataset a statistician receives. If your site keeps trial data on paper CRFs and a spreadsheet, Trialion replaces both, and adds what a regulator asks for: a record of every change that cannot be altered, a real electronic signature, and evidence that only the right people could touch the data.
What it covers
- Designing the study. Case report forms, the visit schedule, which form is collected at which visit, and the automatic checks that run on the data (The form builder).
- Testing and releasing the design. The design is frozen, tested on test data in its own workspace (UAT), signed by three different people and then released to Live.
- Opening sites. Registering a site, recording its ethics approval and activating it so it can enroll.
- Staffing. Adding people to a study or a site, and the investigator's signed delegation of authority for site staff.
- Running participants. Consent, screening, the investigator's eligibility decision, enrollment and the visit schedule generated for each participant.
- Capturing data. Filling in forms at each visit, with checks that run as you save.
- Cleaning data. Queries: questions raised about a value, answered by the site and closed by someone independent.
- Monitoring. A plan for which values a monitor verifies against the source documents, and a queue of what still needs checking.
- Safety. Adverse events, upgrading to serious with a reporting clock, follow-ups, medical review and reconciliation with the safety database.
- Signing and locking. The investigator signs a completed record; it then changes only through a controlled correction that withdraws the signature.
- Closing out. Exports in Excel, CSV or CDISC ODM-XML, and a two-person database lock.
Two applications
| Who uses it | What it holds | |
|---|---|---|
| The trial application | The people of an organization: administrators, study teams, sites, monitors, sponsors, auditors | Studies, people, roles, clinical data and the organization's audit trail |
| The platform console | The platform's own operators (Super-Admins) | The list of organizations, their first administrators, feature switches and the platform ledger. No clinical data |
An administrator reaches the second only by being a Super-Admin; it is described in The platform console.
The words the screens use
| Word | What it means |
|---|---|
| Organization | Your company: a sponsor, a CRO, a site network. It owns its people and studies and never sees another organization's data |
| Study | One clinical trial. Everything else lives inside a study |
| Site | A hospital or clinic taking part in the study |
| Participant (the screens say Subject in places) | A trial participant |
| Visit | A scheduled protocol appointment (screening, baseline, week 4, follow-up) |
| Form | An electronic case report form (eCRF): the page of questions filled in at a visit |
| Record | One participant's answers to one form at one visit. This is what gets signed |
| Query | A question about a value in a record, with a thread of replies |
| SDV | Source data verification: a monitor checking a captured value against the hospital's source document |
| Version | A numbered, sealed snapshot of the whole study design. Forms, visits, mapping and rules go live together as one version |
| Amendment | A new version built beside the Live one after the study is running |
| UAT and Live | The two workspaces of a study: test data for the version under test, and production data for the released version. They are never mixed |
The full glossary, including regulatory terms, is at Glossary.
What Trialion is not
- Not a randomization system (IWRS or IRT). When you randomize a participant you record the allocation; the system issues the next randomization number but does not decide the allocation.
- Not a drug-supply system. Dispensing is captured on forms; inventory and shipments are not tracked.
- Not an eTMF. Study and site documents are stored and versioned in a register, with no trial master file structure.
- Not a safety database. Serious adverse events are recorded with a reporting clock, but the expedited submission to an authority happens in your safety system.
The complete list of gaps, with the regulatory question each answers, is in What is not built yet.