Clinical trials,simplified.
EDC, ePRO, eConsent, randomisation and coding on one continuous data model. AI drafts the forms, the edit checks and the queries — a qualified human reviews and signs every one.
- SUBJ-00482Adverse Events · SeverityOpen
- SUBJ-00139Vital Signs · Blood pressureAnswered
- SUBJ-00251Con Meds · Start dateOpen
- SUBJ-00044Demographics · DOBClosed
Three costs recur on every study.
Each one is a data-architecture problem presented as an operational one.
Vendor fragmentation across BA-BE pipelines.
Volunteer recruitment in one system, randomization in another, dispensing in a third, eCRFs in a fourth — with reconciliation in spreadsheets.
Paper workflows at remote sites.
Unreliable connectivity away from major centres pushes coordinators back to printed CRFs and manual transcription.
Contracts priced in a currency the trial is not.
Platforms that quote in one currency against a budget held in another create margin pressure, and it is sharpest on high-volume, thin-margin work.
One platform. One schema. One audit trail.
Every module reads and writes the same records. There is no reconciliation between modules, because there is no boundary between them.
one schema · one subject record · one immutable audit trail
EDC is live today. The remaining modules are in build on the same model.
External integration will always be a requirement. What changes is that it happens once, at the boundary — not repeatedly between internal modules.
See every supported integrationSee every moduleSpecified by people who ship the lock.
Requirements are written by data managers who have taken a study to database lock, not translated from a brief. The people who know where the hours go decide what gets built.
Build an eCRF without writing code.
Study build takes four to eight weeks of hand-coding on most platforms. Field types, conditional logic and edit checks are assembled here without writing code.
- · Conditional logic without programming
- · Edit checks at the point of entry
- · Amendments deploy without a rebuild
Catch it. Rank it. Draft the query.
Edit checks fire as data lands, not in a monitoring pass weeks later. The discrepancy arrives with subject, site and visit attached, and the site query is drafted and logged to the audit trail.
It then waits. Nothing leaves the platform until a data manager reads it and decides it should.
- 1Detect→
- 2Prioritise→
- 3Draft
Consent date precedes first study procedure
Verify that consent is signed before any visit or drug exposure.
To: Site 04 — Study Coordinator
Re: SUBJ-00214 · Informed consent date
The consent date on the Informed Consent form is blank, but Visit 1 procedures are recorded for 12 Mar. Please confirm the date consent was signed and attach the signed ICF page.
Built for compliance. Engineered for operations.
- Contracts priced in a currency the trial is not
- No native bioequivalence support
- Paper capture at remote sites
- Multi-portal workflows per volunteer
- Data hosted wherever the vendor chooses
- Extended validation cycles before study start
Start with the EDC. Integrate the rest. Inherit the platform as it lands — no re-platforming.
- BA-BE templates structured exactly how a data manager would build them—ready on day one.
- Mobile-first capture with offline sync for low-bandwidth sites
- DPDP Act 2023 aligned, in-region data residency
- Aligned to CDSCO Schedule Y, ICH E6(R3), and Indian GCP
- Single vendor accountable from first entry to database lock
Nine modules. One model underneath.
The EDC is live today. Everything else lands on the same schema and the same audit trail, so nothing has to be migrated when it does.
Trialion launches with the EDC live today on a unified data model. Coming next: eConsent, ePRO / eCOA, CTMS, eTMF, RTSM, Safety, Medical Coding, Data Quality & RBQM.
Compliance sits in the schema, not on top of it.
Audit trails and electronic signatures are properties of the data model, so no module can be configured out of them.
“Most systems we looked at were built for a trial that does not look like ours. Trialion starts from Schedule Y, and from what a coordinator at a remote site can realistically do on the day. The audit trail is the part that holds up when an inspector starts asking.”