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AI-native EDC · built by BITS Pilani and IQVIA alumni

AI agents do the data work. Your team signs it.

Governed agents build your eCRFs, lift lab values from source and draft the queries, all on one data model. Data is clean as it lands, so studies close sooner and site teams get back to patient care.

See it on your protocolHow it works
24 hrs
Sandbox live on your protocol
10 min
Study build, end to end
Part 11
and CDSCO, designed in
A doctor working on a laptop at his desk while a patient sits across from him
The engine

Agents that act. A record that proves it.

Every agent action is staged, source-linked and attributed like a person's work, then waits for a qualified person to sign it.

AI Designer

Reads the protocol and drafts the fields, edit checks and visit schedule in minutes.

AI Capture

Lifts lab values from reports, scores each one and links it to the line it read.

Immutable audit trail

Every machine draft and human signature, attributed and time-stamped for the inspector.

  • CDSCO Schedule Y
  • Indian GCP
  • ICH E6(R3)
  • 21 CFR Part 11
  • CDISC SDTM
  • DPDP Act 2023
How it works

Step by step breakdown

Protocol to signed record in four steps.

  1. A doctor writing notes while a patient sits opposite1
    14 fields drafted from §7.2AI DesignerReview pending

    Draft

    The AI Designer turns a protocol section into fields, logic and edit checks.

  2. A doctor taking a patient's blood pressure2

    Reading central lab report

    • Haemoglobin 13.4 g/dLConfidence 99%
    • Platelets 228 ×10⁹/LConfidence 98%
    • ALT 41 U/LConfidence 96%

    Capture

    AI Capture lifts values from the source document and flags anything it is unsure of.

  3. 3
    9:41Trialion

    Edit check

    Visit 2 · Vital signs

    • SubjectSUBJ-00482
    • CheckCHK-003
    • Systolic148 · above range
    • QueryDrafted

    Waiting for the data manager

    Check

    Edit checks fire as data lands, with the query already drafted for the data manager.

  4. A clinician signing a form on a clipboard4
    21 CFR Part 11
    DraftedReviewedSigned

    Sign

    A qualified person signs and locks. Every step is on the permanent audit trail.

Amendments

Live, versioned, without a rebuild

Amend mid-study in hours, not weeks.

Draft only the delta, test it beside the live version and promote it in about three hours. No pause, no migration.

LIVE · v1.0 · Site 04, Visit 3 · entering dataLIVE · v1.1 · effective 12:05 · sites uninterrupted
Amendment
Protocol amendedDraft

v1.1 is drafted beside the live study. v1.0 keeps running at every site.09:12

Test
Test the changeTest subjects

Only what changed is exercised: entry, checks, derivations and export. Test data never touches production.10:40

Review
A data manager reviews the deltaSign

Reviewer, timestamp and the value before and after go to the audit trail.12:05

Signed
Promote to liveLive

v1.1 takes effect from its date. Sites keep entering, nothing is re-entered, nothing migrates.12:05

Not signed
Back to draftDraft

Nothing reaches a site without a qualified name on it. The live version is untouched.

Features

Run every study on one data model.

Edit everything. No code.

The AI drafts the baseline; your team reshapes forms, conditional logic and edit checks in the same visual builder.

  • Edit checks at entry
  • Queries in one workflow
  • e-Signatures, freeze & lock
  • Amendments without a rebuild

SDTM from day one. Open at the edges.

Every field carries its SDTM mapping from the day it is designed, and your CTMS, RTSM and safety systems connect once at the boundary. Statistics gets a clean handoff on the day of lock.

  • CTMS
  • eTMF
  • eConsent
  • RTSM / IWRS
  • Safety database
  • SDTM export
  • define.xml
Testimonials

What a CRO founder said after the build.

Explore solutionsBook a demo
“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.”
CRO founderClinical research organisation, India
  • 30 minutesTo see it running on your own protocol
  • 10 minutesTo stand a study build up end to end
  • No codeTo build your forms, checks and visit schedule
  • OneData model behind every module
FAQ

What buyers ask first.

What environments do I get?

Every study moves draft → UAT → live, and configuration is promoted between them rather than edited in production. A fully isolated environment for test-subject data is in build — ask us for the date.

Can I amend a study with subjects already enrolled?

Yes. Amendments version the study configuration and deploy without a rebuild, while sites keep entering data on the current version. Bring your own scenario to the demo and we will run it live.

How is my study validated, separately from your platform?

Platform validation is ours: the system is architected to GAMP 5, with the formal exercise run by an external auditor. Study validation — proving your CRFs, checks and visit structure behave to your specification — happens in UAT, with a dedicated QC stage in build.

Can we configure roles beyond PM, DM, CRA, CRC and PI?

Yes. Roles and permissions are configurable at organisation, study and site level, so your own titles map as they are. Field-level restriction is next.

Do we have to use the AI?

No. A study can be built entirely by hand, and nothing the AI drafts takes effect until a qualified person accepts it.

What is retained about an AI-drafted form?

The draft, every human change to it and who approved it, all on the audit trail. The model version and prompt are being added to the same record.

Which study designs is Trialion built for?

Open-label Phase I–IV and bioequivalence studies, including randomised designs with assignments from your IRT. Blinded studies come later, once unblinding and pharmacy roles are airtight.

Contact now

See it on your protocol today.

Bring one protocol section, watch the AI Designer draft it, then take the draft apart yourself. Sandbox live in 24 hours — no scoping call, no quote and no purchase order first.

Book a demoSee pricing
  • CDSCO Schedule Y
  • Indian GCP
  • ICH E6(R3)
  • 21 CFR Part 11
  • CDISC SDTM
  • DPDP Act 2023